Nasal Implants and Methods of Use

ABSTRACT

Described are implants for placing in a body, tools for delivering the implants, and systems and methods for using implants and tools for placing in a body and more particularly to nasal implants, tools for delivering nasal implants, and systems and methods for using such implants and tools.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/440,920, filed Dec. 30, 2016, and titled “NASAL IMPLANTS AND METHODSOF USE”, the entirety of which is incorporated by reference herein.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

The present invention pertains to implants for placing in a body, toolsfor delivering the implants, and systems and methods for using implantsand tools for placing in a body and more particularly to nasal implants,tools for delivering nasal implants, and systems and methods for usingsuch implants and tools.

BACKGROUND

The particular nasal anatomy of an individual may cause or contribute tovarious problems, such as cosmetic concerns, difficulty breathing, sleepapnea, or snoring, and may impact an individual's health or reduce thequality of life. For example, the structure of an external or internalnasal valve may resist airflow from the nose to the lungs and prevent anindividual from getting sufficient oxygen to the blood.

Nasal valve collapse is a frequent cause of nasal airway obstruction,characterized by a loss of support from lateral nasal cartilagestypically observed following rhinoplasty, nasal trauma, or in agedpatients. Properly functioning nasal cartilage acts to keep the nasalpassages open. If the lateral cartilages become weak, they collapseinward when a person inhales due to the negative pressure from the flowof air. This problem is currently largely untreated due to thecomplexity and highly variable results associated with current repairtechniques, combined with the fact that a majority of patients areelderly or have a history of nasal surgery. These complex surgicalprocedures have been developed to correct valve collapse by reinforcingthe lateral cartilages so adequate support can permit valve openings andthus eliminate the nasal airway obstruction.

Overall, nasal valve collapse is an oftentimes untreated problem due toinconsistent results from a myriad of very complex procedures performedby very few surgeons. As such, there remains a need for an endoscopicmethod to repair nasal valves in a simple, consistent manner.

U.S. Pat. Nos. 8,133,276, 7,780,730, and U.S. Patent Publication No.2012/0109298 describe implants that can be introduced into the nasalregion of an individual using non-surgical injection techniques fortreating a nasal valve of an individual. Further, U.S. PatentPublication No. 2016/0058556 describes nasal implants that can be usedto treat the nasal valve of an individual.

However, there is a continued need for improvements to address problemsattributed to nasal anatomy that are easier to use, last longer, areless invasive, are less expensive to manufacture, and work better.

SUMMARY OF THE DISCLOSURE

The present invention relates to nasal implants, systems for deliveringnasal implants, and methods of delivering nasal implants to support anasal valve of an individual.

In general, in one embodiment, a nasal implant includes a central bodyhaving a proximal end and a distal end and first and second armsdisposed at the distal end of the central body. The first arm has aproximal end fixed to the distal end of the central body and a distalend not fixed to the body. The distal end of the first arm is adapted tomove away from a central longitudinal axis of the central body from adelivery configuration toward a deployed configuration. The second armhas a proximal end fixed to the distal end of the central body and adistal end not fixed to the body. The distal end of the second arm isadapted to move away from a central longitudinal axis of the centralbody from a delivery configuration toward a deployed configuration. Thenasal implant further includes a plurality of barbs configured to engagewith tissue when the nasal implant is deployed.

This and other embodiments can include one or more of the followingfeathers. The plurality of barbs can extend from the central body. Theplurality of barbs can extend from the distal end of the central bodyand point towards the proximal end of the central body. The plurality ofbarbs can extend at an angle of 15 degrees or greater relative to thecentral body. There can be two barbs, and the two barbs can extend fromopposing surfaces of the central body. There can be a plurality of barbsthat extend down each of the opposing surfaces, and the plurality ofbarbs on each surface can have a staggered configuration along thecentral body. The plurality of barbs can extend from the first arm andsecond arm. The plurality of barbs can extend from an outer surface ofthe first arm and an outer surface of the second arm away from thecentral longitudinal axis of the central body. The plurality of barbscan extend from an inner surface of the first arm and an inner surfaceof the second arm towards the central longitudinal axis of the centralbody. The plurality of barbs on each arm can have a staggeredconfiguration. The plurality of barbs can extend in line or parallelwith a plane formed by the first arm and the second arm in the deployedconfiguration. The plurality of barbs can extend transversely to a planeformed by the first arm and the second arm in the deployedconfiguration. The plurality of barbs each can have a complementaryshape to a plurality of openings on the central body or the first andseconds arm such that, when the nasal implant is in the deliveryconfiguration, the plurality of barbs are engaged with the openings onthe central body or the first and second arms. The plurality of barbscan have a notch or tooth configuration. The implant can further includea plurality of openings in the central body portion adapted to allowtissue ingrowth. The implant can further include a plurality of openingsin the first and second arms adapted to allow tissue ingrowth. Thecentral body can include a hollow or open structure along a centrallongitudinal axis of the implant. The central body can include a solidstructure along a central longitudinal axis of the implant. The centralbody can include a closed pitch spiral configuration. The central bodycan include a uni-directional helix spiral configuration. The centralbody can include a bi-directional helix spiral configuration. Thecentral body can include an open coil configuration. The central bodycan include a solid shaft with a spiral cut outer surface. The centralbody can include a solid shaft with a dual, bi-directional spiral cutouter surface. The implant can further include a first faceted tip onthe distal end of the first arm and a second faceted tip on the distalend of the second arm. The implant can further include a first sharpenedtip on the distal end of the first arm and a second sharpened tip on thedistal end of the second arm. The faceted tip or sharpened tip caninclude a surface formed from a planar cut at an angle of 45 degrees orless. The faceted tip or sharpened tip can include a surface formed froma planar cut at an angle of 35 degrees or less. The faceted tip orsharpened tip can include two or more surfaces formed from planar cuts.The first arm and the second arm can have an offset configuration suchthat, in the delivery configuration, the first arm and second armoverlie each other along or adjacent to the central longitudinal axis ofthe body. The body can consist essentially of a bioabsorbable material.At least one portion of the implant can be composed of a bioabsorbablematerial. The nasal implant can include two or more different materials.The implant can be made of a material selected from the group consistingof: a poly(lactide); a poly(glycolide); a poly(lactide-co-glycolide); apoly(lactic acid); a poly(glycolic acid); a poly(lactic acid-co-glycolicacid); poly(lactide)/poly(ethylene glycol) copolymers; apoly(glycolide)/poly(ethylene glycol) copolymers; apoly(lactide-co-glycolide)/poly(ethylene glycol) copolymers; apoly(lactic acid)/poly(ethylene glycol) copolymers; a poly(glycolicacid)/poly(ethylene glycol) copolymers; a poly(lactic acid-co-glycolicacid)/poly(ethylene glycol) copolymers; a poly(caprolactone);poly(caprolactone)/poly(ethylene glycol) copolymers a poly(orthoester);a poly(phosphazene); a poly(hydroxybutyrate) or a copolymer including apoly(hydroxybutyrate); a poly(lactide-co-caprolactone); a polycarbonate;a polyesteramide; a polyanhidride; a poly(dioxanone); a poly(alkylenealkylate); a copolymer of polyethylene glycol and a polyorthoester; abiodegradable polyurethane; a poly(amino acid); a polyetherester; apolyacetal; a polycyanoacrylate; a poly(oxyethylene)/poly(oxypropylene)copolymer, poly-L-lactic acid (PLLA), poly-D-lactic acid (PDLA),poly-D,L-lactic acid (PLDLLA), or a blend or copolymer thereof. Theproximal end can include an atraumatic rounded tip. An outer surface ofthe nasal implant can include a plasma treated portion. The plasmatreated portion can have an increased hydrophilicity. The plasma treatedportion can have an increased hydrophobicity.

In general, in one embodiment, a nasal implant includes a central bodyhaving a proximal end and a distal end and first and second armsdisposed at the distal end. The first arm has a proximal end fixed tothe distal end of the central body and a distal end not fixed to thebody. The distal end is adapted to move away from a central longitudinalaxis of the central body from a delivery configuration toward a deployedconfiguration. The second arm has a proximal end fixed to the distal endof the central body and a distal end not fixed to the body. The distalend of the second arm is adapted to move away from a centrallongitudinal axis of the central body from a delivery configurationtoward a deployed configuration. The implant has a first stiffness alonga first plane of the central body and a second stiffness along a secondplane of the central body.

This and other embodiments can include one or more of the followingfeatures. The first plane can be formed by the first arm and the secondarm in the deployed configuration. The second stiffness can be less thanthe first stiffness. The first stiffness or the second stiffness can beabout 70 N*mm2 to about 150 N*mm2. The first stiffness or the secondstiffness can be about 90 N*mm2 to about 105 N*mm2. The second plane canbe orthogonal to the first plane. The implant can further include: astiffness modification adapted to provide the first stiffness and thesecond stiffness. The stiffness modification can include one or morenotches or grooves along at least a portion of a longitudinal length ofthe central body. The stiffness modification can include flattenedsurfaces on opposing sides of the central body. The stiffnessmodification can include a stress distributing rib along the length ofthe flattened surfaces. The stiffness modification can include one ormore openings along the central body. The stiffness modification caninclude a hollow core along the central body. The stiffness modificationcan include a tapered cross-section along an axis of the central bodywith a larger cross-section adjacent the distal end and a smaller sizetowards the proximal end. The stiffness modification can include thecentral body having a plurality of different cross-section sizesincluding a first cross-section adjacent the distal end of the centralbody, a second-cross section adjacent the first-cross-section, and athird cross-section adjacent to the second-cross-section and theproximal end of the central body, the first cross-section can be largerthan the second-cross section and the second cross-section is largerthan the third cross-section. The stiffness modification can include ascalloped pattern on an outer surface of the central body. The stiffnessmodification can include a stiff inner material and a more flexibleouter material. The stiffness modification can include the central bodyhaving a patterned outer surface with undulations having a varyingfrequency. The stiffness modification can include a plurality ofdirectional fibers within the implant. The stiffness modification caninclude a patterned second material on an outer surface of the centralbody. The stiffness modification can include a repeating pattern on anouter surface of the central body with a first larger cross-section anda second smaller cross-section. The stiffness modification can include aplurality of articulating sections that provide flexibility along aplane orthogonal to the plane defined by the first arm and the secondarm in the deployed configuration. The central body can have a taperingoutside diameter that decreases from the distal end towards the proximalend. The central body can include a plurality of undulations therein. Adiameter of the undulations can increase from the distal end to theproximal end. The central body can include a tapered core therein suchthat the diameter of the inner core decreases from the distal end to theproximal end. There can be between 6 and 24 undulations along an entirelength of the central body. The implant can further include a pluralityof openings in the central body portion adapted to allow tissueingrowth. The implant can further include a plurality of openings in thefirst and second arms adapted to allow tissue ingrowth. The central bodycan include a hollow or open structure along a central longitudinal axisof the implant. The central body can include a solid structure along acentral longitudinal axis of the implant. The central body can include aclosed pitch spiral configuration. The central body can include auni-directional helix spiral configuration. The central body can includea bi-directional helix spiral configuration. The central body caninclude an open coil configuration. The central body can include a solidshaft with a spiral cut outer surface. The central body can include asolid shaft with a dual, bi-directional spiral cut outer surface. Theimplant can further include a first faceted tip on the distal end of thefirst arm and a second faceted tip on the distal end of the second arm.The implant can further include a first sharpened tip on the distal endof the first arm and a second sharpened tip on the distal end of thesecond arm. The faceted tip or sharpened tip can include a surfaceformed from a planar cut at an angle of 45 degrees or less. The facetedtip or sharpened tip can include two or more surfaces formed from planarcuts. The first arm and the second arm can have an offset configurationsuch that, in the delivery configuration, the first arm arm and secondarm overlie each other along or adjacent to the central longitudinalaxis of the body. The body can consist essentially of a bioabsorbablematerial. At least one portion of the implant can be composed of abioabsorbable material. The nasal implant can include two or moredifferent materials. The implant can be made of a material selected fromthe group consisting of: a poly(lactide); a poly(glycolide); apoly(lactide-co-glycolide); a poly(lactic acid); a poly(glycolic acid);a poly(lactic acid-co-glycolic acid); poly(lactide)/poly(ethyleneglycol) copolymers; a poly(glycolide)/poly(ethylene glycol) copolymers;a poly(lactide-co-glycolide)/poly(ethylene glycol) copolymers; apoly(lactic acid)/poly(ethylene glycol) copolymers; a poly(glycolicacid)/poly(ethylene glycol) copolymers; a poly(lactic acid-co-glycolicacid)/poly(ethylene glycol) copolymers; a poly(caprolactone);

poly(caprolactone)/poly(ethylene glycol) copolymers a poly(orthoester);a poly(phosphazene); a poly(hydroxybutyrate) or a copolymer including apoly(hydroxybutyrate); a poly(lactide-co-caprolactone); a polycarbonate;a polyesteramide; a polyanhidride; a poly(dioxanone); a poly(alkylenealkylate); a copolymer of polyethylene glycol and a polyorthoester; abiodegradable polyurethane; a poly(amino acid); a polyetherester; apolyacetal; a polycyanoacrylate; a poly(oxyethylene)/poly(oxypropylene)copolymer, poly-L-lactic acid (PLLA), poly-D-lactic acid (PDLA),poly-D,L-lactic acid (PLDLLA), or a blend or copolymer thereof. Theproximal end can include an atraumatic rounded tip. An outer surface ofthe nasal implant can include a plasma treated portion. The plasmatreated portion can have an increased hydrophilicity. The plasma treatedportion can have an increased hydrophobicity.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a diagram of the structural anatomy and tissues of the face.

FIGS. 2A-2B show front and side views of an exemplary implant in apatient's nasal anatomy.

FIGS. 3A-3B show a nasal implant with grooves configured to providemodified stiffness.

FIGS. 4A-4C illustrate the relationship between the cross-sectionalprofile of a material and the moment of inertia.

FIGS. 5A-5B show a nasal implant with a tapered cross-section thatprovides modified stiffness.

FIG. 6 shows a nasal implant with through-holes along the central bodythat provide modified stiffness.

FIGS. 7A-7D show various embodiments of nasal implants with differentsurface modifications and cross-sectional shapes to provide modifiedstiffness.

FIGS. 8A-8B show additional embodiments of nasal implants that can havemodified stiffness.

FIGS. 9A-9C show additional embodiments of nasal implants that can havemodified stiffness.

FIGS. 10A-10B show embodiments of nasal implants made of a compositestructure for modified stiffness.

FIG. 11 shows a nasal implant having a non-contiguous coating that canbe used to tune the degradation profile of the implant.

FIG. 12 shows an exemplary method of creating the coating on the implantof FIG. 11.

FIG. 13 shows a nasal implant with anchoring features that are deployedby a suture.

FIG. 14 shows a nasal implant with a patterned surface to provideanchoring of the implant.

FIG. 15 shows a nasal implant with hollow sections that provide tissueingrowth for anchoring of the implant.

FIG. 16 shows a nasal implant with barbs configured to prevent migrationof the implant.

FIG. 17 shows a nasal implant with an etched pattern to provide modifiedstiffness.

FIG. 18 shows the central body of a nasal implant that includes acombination of grooves and barbs.

FIG. 19 shows a nasal implant including scalloped features to providemodified stiffness.

FIG. 20A shows a nasal implant with two rounded atraumatic ends. FIG.20B shows the implant of FIG. 20A positioned within the nasal anatomy.

FIG. 21 shows a nasal implant with an overmolded pattern that providesmodified stiffness.

FIGS. 22A-22C show a nasal implant that includes articulating sections.

FIG. 23 shows a nasal implant including barbed segments.

FIGS. 24A-24B show a nasal implant having a laser cut cylindricalpattern for modified stiffness.

FIG. 25 shows a nasal implant with a helical grooved scallop extendingtherearound.

FIGS. 26A-26F show additional embodiments of nasal implants.

FIGS. 27A-27F show additional embodiments of nasal implants.

FIG. 28 illustrates a central body of nasal implant that includes aclosed pitch spiral shaft.

FIG. 29 illustrates a central body of a nasal implant with auni-directional helix spiral shaft.

FIG. 30 illustrates a central body of a nasal implant with an open coilshaft.

FIG. 31 illustrates a central body of a nasal implant with a solid shaftand a spiral outer cut in the surface.

FIG. 32 illustrates a central body of a nasal implant that includes asolid shaft having a dual, bi-directional spiral cut.

FIG. 33 illustrates a central body of a nasal implant that includes abi-directional helix spiral shaft.

FIGS. 34A-34B show a nasal implant with flattened surfaces and scallopedor ridged surfaces therebeween for modified stiffness.

FIGS. 35A-35C show a nasal implant with barbs on the inner portions ofthe arms of the implant.

FIG. 36 shows a nasal implant with barbs that are designed to fold outfrom the central body.

FIG. 37 shows a nasal implant with barbs projecting from opposing sidesof the central body.

FIG. 38 shows a nasal implant with barbs projecting from opposing sidesof the central body.

FIGS. 39A-39D show additional embodiments of nasal implants with barbsthereon.

FIGS. 40A-40B show a nasal implant with notches thereon.

FIGS. 41A-41B show a nasal implant with a plurality of transversenotched projections on the arms.

FIGS. 42A-42B show a nasal implant with barbs extending outwards fromthe arms.

FIGS. 43A-43B show a nasal implant with two barbs at the necked regionof the implant.

FIGS. 44A-44B show another nasal implant with two barbs at the neckedregion of the implant.

FIGS. 45A-45B show a nasal implant with a plurality of barbs extendingoutwards from the arms.

FIGS. 46A-46B show another nasal implant with a plurality of barbsextending outwards from the arms.

FIGS. 47A-48B show a nasal implant with a plurality of small barbsextending from the inside surface of each of the arms.

FIGS. 48A-48B show another nasal implant with a plurality of small barbsextending from the inside surface of each of the arms.

FIGS. 49A-49B show another nasal implant with a plurality of small barbsextending from the inside surface of each of the arms.

FIGS. 50A-50B show another nasal implant with two barbs at the neckedregion of the implant.

FIGS. 51A-51B show another nasal implant with two barbs at the neckedregion of the implant.

FIGS. 52A-52B show another nasal implant with two barbs at the neckedregion of the implant.

FIGS. 53A-53B show a forked distal end of a nasal implant that includessharp faceted tips on the arms.

FIGS. 54A-54B show another forked distal end of a nasal implant thatincludes sharp faceted tips on the arms.

FIGS. 55A-55B show a forked distal end of a nasal implant in which thearms are offset from one another.

FIGS. 56A-56C show a nasal implant with an outer undulating pattern formodified stiffness.

FIGS. 57A-57D show a nasal implant with a stress distribution rib alongthe central body.

FIGS. 58A-58C show a nasal implant with a tapered outer diameter.

FIGS. 59A-59B show a nasal implant with barbs thereon.

FIGS. 60A-60B show another nasal implant with two barbs at the neckedregion of the implant.

FIGS. 61A-61C show another nasal implant with two barbs at the neckedregion of the implant.

FIG. 62 shows compressed wings that can be used with a nasal implant.

DETAILED DESCRIPTION

Described herein are devices configured for suspending nasal valves.Specifically, described herein are implants used to support the upperand lateral cartilage.

In some embodiments, the nasal implants described herein can include acentral body, two arms, and one or more tissue engagement structures,such as barbs, to improve engagement between the implant and the nasalanatomy. The tissue engagement structures can be on the central bodyand/or on the arms. In some embodiments, the barbs can include aplurality of tiny barbs that can prevent the withdrawal of the implant.The tiny barbs can be formed with a small cut or slit in the exterior ofthe implant.

In some embodiments, the nasal implants described herein can includesections with preferential bending or stiffness along differentdimensions and at different areas of the implant. The implants can berelatively stiff in some directions to support the nasal valve whileallowing bending in other directions to improve movement with the nasalanatomy.

In some embodiments, the nasal implants can also include a sharpenedsurface to improve the ability of the nasal implant to pierce nasaltissue. In one example, the implant includes a faceted tip.

The size, geometry, and configurations of the nasal implants describedherein can be selected to provide the desired amount of support to thebody tissue adjacent to the desired implant location. For example, thenasal implant can be relatively stiff in the area adjacent to the nasalvalve while being relatively flexible along proximal portions of theimplant to move with more flexible portions of the nasal tissue.

FIG. 1 shows the underlying structural anatomy and tissues of a face.The outer layers of overlying skin and muscle have been removed tobetter show the underlying cartilage and bone that provide structure.The nose sits in the middle of the face and has importantresponsibilities in olfaction (smelling) and controlling respiration.The nose controls respiration by restricting the flow of air. The nosehas two airflow pathways, one on each side of the nose (starting witheach nostril) which combine to form a single airflow pathway into thebody. Air from the nose flows through the trachea and into the lungswhere the air is spread out in the lobules of the lungs and oxygen isabsorbed for use by the entire body. Each of the two airflow pathways inthe nose has several segments including two types of nasal valves(called external nasal valves and internal nasal valves) along eachnasal airflow pathway that act to control airflow through the nose andso together the external and internal valves control airflow into andout of the body. The amount of airflow resistance caused by the valvesneeds to be “just right”; either too much or too little resistancecauses breathing and other problems. The valves are tissues thatsurround the airflow and the amount of resistance they provide to theairflow is determined largely by their shape and their size (theirinternal cross-sectional area). The internal nasal valve on each pathwayis the narrowest segment of the pathway in the nose and generallycreates most of the resistance. Besides the important function ofcontrolling airflow, the internal nasal valves also help give the noseits distinctive shape. A nasal valve is shaped and supported by variousstructures in the nose and face, with upper lateral cartilage playing asignificant role in its form and function. Large and even small changesin internal nasal valve structure can impair nasal breathing, as well aschange the cosmetic appearance of the nose. These changes generally actto reduce the cross-sectional area of the internal valve, and can becaused by surgery, another medical treatment, or trauma to the face.Additionally, there are variations of nasal valve structure betweenindividuals, with some individuals having significantly narrowed valvesdue to weakened or misshaped cartilage, commonly observed as a pinchednose. A narrowed valve region increases the acceleration of airflow andsimultaneously decreases intraluminal pressure, causing the valves tocollapse. While even normal nasal valves can collapse under greatrespiratory pressures, dysfunctional internal valves can collapse evenduring normal breathing, with reduced oxygen flow, snoring and mouthbreathing as undesirable consequences.

The nose includes the external nose that protrudes from the face and anasal cavity underneath the external nose. From top to bottom, theexternal nose has a root, a bridge, a dorsum (ridge), a free tip (apex),and a columella. The external nose is appended to the piriform aperture,the continuous free edges of the pear shaped opening of the nasal cavityin the skull and is formed by the nasal bones and the maxilla. As shownin FIG. 1, the nose sits in the middle of the face, framed by the bonesof the head, with frontal bone 2 superior to the nose, lateral maxillafrontal process 6 lateral to it, and the maxilla anterior nasal spine 20inferior to it (another lateral maxilla frontal process on the otherside of the nose is not visible in this view). The external nose can beroughly divided into three layers from outside to inside: an overlyingskin and muscle layer (removed in this view), a middle cartilage andbony framework layer, and an inner mucosal layer (not readily visible inthis view).

While the middle cartilage and bony framework layer provides form,structure, and support to the nose, it is also organized to allow thenose to be flexible and wiggle and bend in different directions. It canalso be roughly divided into three sections: from top to bottom, theyare an upper (superior) bony third, and middle and lower (inferior)cartilaginous thirds. The upper third includes paired left nasal bone 4a and right nasal bone 4 b that are joined in the middle of the nose andform the top (or superior) part of the bridge of the nose. Nasal bone 4a (along with lateral maxilla frontal process 6) joins frontal bone 2superiorly to form the nasofrontal (nasion) suture line 5. Laterally,nasal bone 4 a joins the maxilla at its frontal process 6 to form afibrous joint at the maxilla nasal bone suture line 7 (or nasomaxillarysuture line). The middle third of the cartilage and bony framework layerincludes septal cartilage 10 which forms part of the septum of the noseand internally separates the nostrils and the two airflow pathways.Lateral process 8 of septal cartilage 10 merges superiorly with upperlateral cartilage 11 (another lateral process on the other side of thenose that merges with upper lateral cartilage on the other side of thenose is not visible in this view). FIG. 1 also shows minor alarcartilage 24, one of several accessory cartilages which provide supportand allow movement of the nose, and which impact the complex3-dimensional shape of the nose. Upper lateral cartilage 11 is normallyfairly stiff and it has much of the responsibility for supporting theside of the nose. In conjunction with septal cartilage tissue, it helpsto form the internal nasal valve, which is inside the nose under theupper lateral cartilage and not readily visible in this view. Asmentioned above, there are two internal nasal valves (one on either sideof the nose). Each internal nasal valve is formed by and borderedmedially by septal cartilage 10, laterally by the caudal margin 13 ofthe upper lateral cartilage, and inferiorly by the head of inferiorturbinate (not visible in this view) and surrounds an opening throughwhich air flows. The attachment of the upper lateral cartilage to theseptum (septal cartilage) forms an angle that defines the internal nasalvalve angle (also called simply “valve angle”). The internal nasal valveangle is the narrowest part of the nasal airway and creates resistancethat controls airflow through it. There is some natural variationbetween individuals in their nasal valve angles, and valve angles maychange over time as a natural consequence of aging. Valve angle isdetermined in part by genetics, and an ethnic group has a particularaverage valve angle associated with it. There is also variation in valveangles between individuals, even within a particular ethnic group, andbetween an individual's left and right valves. Nasal valve angles mayalso be altered as a result of surgery, trauma or another intervention.A valve with a valve angle of less than about 10 degrees may generallybe considered collapsed, causing nasal airway obstruction with nasalsidewall collapse upon inspiration and may merit treatment such asdescribed herein. A valve angle that is greater 10 degrees may alsocause some airway obstruction, cosmetic concern or another concern andmay also merit treatment but its dysfunction is generally not as severeas a collapsed valve. Valves in need of treatment may be candidates fortreatment using the implants, devices, systems and methods describedherein.

The lower third of the cartilage and bony framework layer includes majoralar cartilage (also referred to as lower lateral cartilage or inferiorlateral cartilage, based on its location and to distinguish it fromupper lateral cartilage) that help shape the nostrils and the tip of thenose. This cartilage is softer and more mobile than upper lateralcartilage, and it allows the tip of the nose to move. Major alarcartilage 14 is U-shaped and includes lateral crus 16 and medial crus18. Major alar cartilage 14 forms part of external valve around nostril17 (also called nares), though it does not quite reach the bonelaterally. The lower third of the cartilage and bony framework layeralso includes alar fibrofatty tissue 26 of alar that fills the gapbetween lateral crus 16 and the bone. FIG. 1 also shows small accessoryalar cartilage 12 that links the major alar and lateral cartilage 8 ofthe cartilage and bony framework layer.

As mentioned above, the nose is a complex, 3-dimensional structure. Itmay be desirable to change its shape or better support its structure inorder to improve or maintain its function or appearance (cosmesis), butit can be difficult to change one aspect of the nose without adverselyaffecting another part. Indeed, previous surgical interventions are onecause of altered nasal valve function that may be treated using thesystems and methods described herein. Described herein are implants,devices, systems and methods function for changing or supporting anaspect of a body structure or shape, including of the nose.

FIGS. 2A-2B show front and side views, respectively, of an exemplaryimplant 32 implanted in a patient's nose and supporting a tissue sectionof a patient's nose. The implant 32 has a body with a proximal end 34, adistal end 36, and a central body 38 between the proximal and distalends. The distal end 36 of implant 32 is forked with first arm 40 andsecond arm 42 forming the tines of the fork. Each arm 40, 42 has aproximal end fixed to the central body 38 of the implant body and adistal free end not fixed to the central body 38. Further, the centralbody 38 may include one or more ribs 80 (also called ridges) thereon.The implant 32 can have one or more ribs 80 or other body features, suchas a bevel, scallop, or wing.

The implant 32 may be useful for maintaining or improving nasal functionor appearance. FIGS. 2A-2B show implant 32 in place for supporting orchanging an internal nasal valve. The implant 32 can appose structuresin the cartilage and bony framework layer under the skin and muscle. Thecentral body 38 is in a position between the nasal cartilage and patientskin or muscle and apposes upper lateral cartilage 11 and lower lateralcartilage 51. As such, the central body 38 can appose the caudal end 48of the upper lateral cartilage 11 and so overlay or acts on the internalvalve wall, providing support to or changing a shape of the internalvalve. The distal end 36 of implant 32 apposes structures in the upperpart of the cartilage and bony framework layer. Further, in thisexample, the arms 40, 42 appose nasal bone 4 a, frontal process 6 of themaxilla bone, and maxilla nasal bone suture line 7 (nasomaxillary sutureline). The ribs 80 can help anchor an implant in place, such as bycatching tissue against the rib, valley, or otherwise. In somevariations, a distal end of the implant 32 may be apposed or inproximity to one of more structures in the upper layer or any of thestructures or tissues in the middle or lower cartilage and bonyframework layer (e.g., accessory cartilage, major alar cartilage, minoralar cartilage, septal cartilage, maxilla, etc.).

The nasal implant 32 can have a forked end that anchors and remainsparallel to the nasal bone/maxilla bone construct of the nose. Thisgeometric feature can help ensure that the nasal implant 32 remains in aknown orientation after implantation. Additional features on the implant32, such as barbs, can be used as orientation features that allow theimplant features to be designed to provide support in the same plane asthe deflection of the nasal valve collapse.

Because the implant 32 has features that enable exact placement andorientation of the implant, designing implant geometries with preferredstiffness in specifically selected orientations is possible. The nasalimplant 32 can thus be designed to incorporate preferential stiffness orflexibility in a plane or orientation of choice by the designer. Theimplant 32 can be selectively created to be stiff in one orientation andless stiff or flexible in another (e.g., stiff in an orientation normalto the lower lateral or upper lateral cartilage and more flexible in theorientation parallel to these structures to provide improved support ofthe cartilages and nasal valve).

In some embodiments, implant features, such as a non-roundcross-section, layered materials of different molecular weight,intrinsic viscosity, and different compositions of Poly(L-lactide)(PLLA), Poly(D-lactide) (PDLA), Poly(L-lactide-co-D-lactide) (PLDA),Poly(L-lactide-co-D,L-lactide) (PLDLLA), Poly(D,L-lactide) (PDLLA),Polyglycolic Acid (PGA), Polycaprolactone (PCL), Poly(dioxanone) (PDS),their copolymers and combinations thereof, can be used to impartpreferential stiffness in one plane and not the other plane(s) ofimplant 32.

In some embodiments, grooves or scallops along the length of the implant32 can preferentially make the implant less stiff in one plane and morestiff in another. The grooves or scallops can be spaced unevenly toprovide for different stiffness at different parts of the implant 32.For example, the implant 32 can be designed to be stiff in one directionto keep the nasal valve open but allow movement of the nasal tissue. Inyet another example, a separate member of the nasal implant 32 can beclipped in to give preferential stiffness. In yet another example,articulating sections can be used for the implant 32 that allow freemovement until they reach a certain point and then movement stops. Inanother example, the nasal implant 32 can be made from a stiff core withoriented fibers and injection molding on top of the stiff core. Inanother example, patterns can be formed on the nasal implant 32 tomodulate stiffness, e.g., through laser cutting. In another example,molding patterns can be used to mold at different thicknesses in oneplane to achieve preferential stiffness for the implant 32.

In some embodiments, the implant 32 can have a first flexural rigidityor first stiffness along a plane formed by the first arm and second armin the deployed configuration. The implant 32 can have a second flexuralrigidity or second stiffness along a plane other than the plane formedby the first arm and second arm in the deployed configuration. Thesecond flexural rigidity or second stiffness can be less than the firstflexural rigidity or first stiffness. The flexural rigidities of thenasal implant 32 can be designed to vary from 0-300% or more between theplane formed by the arms to other planes of the implant. The plane otherthan the plane formed by the first arm and second arm in the deployedconfiguration can be orthogonal to the plane formed by the first arm andsecond arm in the deployed configuration. In some embodiments, the nasalimplant 32 can have three or more different flexural rigidities in threeor more different planes/sections.

In some embodiments, the flexural rigidity can vary along an axiallength of the nasal implant 32. The flexural rigidity can vary graduallyalong the axial length of the nasal implant 32, for example, with atapered profile or configuration.

In some embodiments, the flexural rigidity or stiffness at a specificpoint along the axial length of the nasal implant 32 can beomnidirectional, non-planer, or symmetrical. For nasal implants with asymmetrical cross-section, the flexural rigidity can be omnidirectionalat that specific point of the nasal implant 32.

In some embodiments, the implant 32 can have a first flexural rigidityor first stiffness at a first portion of the central body. The firstflexural rigidity or first stiffness at the first portion of the centralbody can be symmetrical or omnidirectional. In some embodiments, theimplant 32 can have a second flexural rigidity or second stiffness at asecond portion of the central body. The second flexural rigidity orsecond stiffness at the second portion of the central body can besymmetrical or omnidirectional.

In some embodiments, the nasal implant geometry of the implant 32 canform regions of flexural rigidity relative to the plane formed by thearms along with a tiered or gradual increase or decrease in flexuralrigidity along the axis of the nasal implant. These geometries caninclude parallel elongate features that run alongside the device, whichare tapered to create a gradual change in flexural rigidity. Thegeometries can also include inclusions such as flutes or grooves, ofvarying size and shape, which change the relative rigidity of the devicealong its axis by changing the effective cross section of the devicealong its axis.

Any of the flexural rigidities in the nasal implant 32 can be combinedor substituted for one another. For example, the nasal implant 32 canhave a flexural rigidity adjacent to the forked end in a plane definedby the arms of the fork, along with a tapered longitudinal configurationwhere the flexural rigidity decreases from the forked end to theproximal end.

The specific flexural rigidity profile of the nasal implant 32 can bepre-selected to match the properties to the desired clinical use. Forexample, the stiffness or flexural rigidity can be selected in someimplant areas to support or match the properties of nasal tissue likethe lateral nasal cartilage. The flexural rigidity and stiffness canalso be selected to minimize the stress concentration and distributionsalong the length of the implant while also minimizing the maximum stresswhile bending.

The stiffness of the implant 32 can be selected based on matching thestiffness of native nasal cartilage. However, depending on the goals ofnasal implant 32, the implant design can also be purposefully intendedto be more or less flexible than the native nasal cartilage. Forexample, implants intended to support the lateral wall can have aflexural rigidity of about 70 N*mm² to about 150 N*mm² or 90 N*mm² toabout 105 N*mm². In some embodiments, the device can have a firstflexural rigidity of about 70 N*mm² to about 150 N*mm², such as about 90N*mm² to about 105 N*mm². In some embodiments, the device can have asecond flexural rigidity of about 70 N*mm² to about 150 N*mm², such asabout 90 N*mm² to about 105 N*mm². The stiffness of native nasalcartilages can range from 1.5 N*mm² for lower lateral cartilage to 220N*mm² for septal cartilage grafts. Thus, embodiments can be envisionedto have first and second flexural rigidities within this range dependingon the desired goals of the implant.

In some embodiments, the flexural rigidity or stiffness profile can bepre-selected and implemented by a stiffness modification to the nasalimplant 32, in particular the profile and configuration of the centralbody of the nasal implant. In one example, the stiffness modificationcan be adapted to provide the first flexural rigidity or first stiffnessand the second flexural rigidity or second stiffness.

A number of different stiffness modifications are illustrated anddescribed herein.

In one example, the stiffness modification includes one or more notchesor grooves along all or a portion of a longitudinal length of thecentral body. Examples of grooves and notches are shown in FIGS. 3A-3Band 7A-7C.

In one example, the stiffness modification includes flattened surfaceson opposing sides of the central body. An example of flattened surfacesis shown in FIGS. 34A-34B.

In one example, the stiffness modification includes one or more openingsalong the central body. An example of a nasal implant with one or moreopenings is shown in FIGS. 6 and 15.

In one example, the stiffness modification includes a hollow core alongall or a portion of the central body. In some cases, the implant canhave a plurality of discontinuous hollow portions in the central body.

In one example, the stiffness modification includes a taperedcross-section along an axis of the body with a larger cross-sectionadjacent the distal end and a smaller cross-section size towards theproximal end. An example of a tapered nasal implant is shown in FIGS.5A-5B and 7A-7C.

In one example, the stiffness modification can include the central bodyhaving a generally tapering outside diameter from the distal end towardsthe proximal end. An example of a nasal implant with a generallytapering outside diameter is shown in FIGS. 57A-57D and 58A-C.

In one example, the stiffness modification includes a stressdistributing rib or ridge along a portion of the length of the centralbody. The stress distributing rib or ridge can be on opposing sides ofthe nasal implant. The stress distributing rib or ridge can bepositioned on opposing flattened surfaces of the central body of theimplant. An example of a nasal implant with a stress distributing rib isshown in FIGS. 57A-57D.

In some embodiments, the stiffness modification can be along a portionof the central body. For example, when the central body includes aplurality of undulations with an inner diameter and an outer diameter,the stiffness modification can include the central body having a taperedcore section defined generally by the inner diameter of the undulations.The tapered core section can start at a predetermined offset distancefrom the outer diameter of the undulations. An example of such a nasalimplant is shown in FIGS. 57A-57D.

In one example, the stiffness modification includes the central bodyhaving a plurality of different cross-section sizes, including a firstcross-section adjacent the distal end of the central body, asecond-cross section adjacent the first-cross-section, and a thirdcross-section adjacent to the second-cross-section and the proximal endof the central body. The first cross-section can be larger than thesecond-cross section and the second cross-section can be larger than thethird cross-section. An example is shown in FIGS. 7A-D. In someembodiments, the cross-section can increase from the proximal to thedistal end.

In one example, the stiffness modification includes a scalloped patternon an outer surface of the central body. Examples are shown in FIGS. 19and 25.

In one example, the stiffness modification includes a stiff innermaterial and a more flexible outer material. An example is shown in FIG.14.

In one example, the stiffness modification includes the central bodyhaving a patterned outer surface with undulations having a varyingfrequency. Examples are shown in FIGS. 7A-D and 26A-F.

In one example, the stiffness modification includes a plurality ofdirectional fibers within the implant. The directional fibers can becoated by another material or can be on a portion of the outer area ofthe implant. An example is shown in FIGS. 10A-10B.

In one example, the stiffness modification includes a patterned secondmaterial on an outer surface of the central body. The stiffness of theimplant can be increased in the region with the patterned material. Anexample is shown in FIG. 17.

In one example, the stiffness modification includes a repeating patternon an outer surface of the central body with a first largercross-section and a second smaller cross-section. An example is shown inFIG. 16.

In one example, the stiffness modification includes a plurality ofarticulating sections that provide flexibility along a plane orthogonalto the plane defined by the first arm and the second arm in the deployedconfiguration. Examples are shown in FIGS. 16, 22A-C, and 23.

A number of different implant features are illustrated and describedherein.

In some embodiments, the central body includes a hollow or openstructure along the central longitudinal axis of the body. The centralbody can include a closed pitch spiral configuration, such as theconfiguration illustrated in FIG. 28. The central body can include auni-directional helix spiral configuration, such as the figurationillustrated in FIG. 29. The central body can include a bi-directionalhelix spiral configuration, such as the figuration illustrated in FIG.33. The central body can include an open coil configuration, such as thefiguration illustrated in FIG. 30. Combinations of any of theseconfigurations can be used to achieve a desired stiffness profile alongthe axis of the central body along with a desired amount of tissueingrowth.

In some embodiments, the central body includes a solid or closedstructure along the central longitudinal axis of the body. The centralbody can include a solid shaft with a spiral cut outer surface, such asthe figuration illustrated in FIG. 31. The central body can include asolid shaft with a dual, bi-directional spiral cut outer surface, suchas the figuration illustrated in FIG. 32.

A distal end of the arms of the implant can include a sharpened orfaceted tip. FIGS. 53A-55B illustrate several examples of faceted tips.The sharpened or multi-faceted distal end of the arms can include abeveled face in at least two directions. The sharpened or faceted tipwith multiple edges can result in a point for piercing tissue ratherthan just a cutting edge if the edge has only one plane. In someembodiments, the faceted tip or sharpened tip includes a surface formedfrom a planar cut at an angle of 45 degrees or less. In someembodiments, the faceted tip or sharpened tip includes a surface formedfrom a planar cut at an angle of 35 degrees or less. In someembodiments, the faceted tip or sharpened tip includes two or moresurfaces formed from planar cuts.

In some embodiments, the first arm and the second arm have an offsetconfiguration such that, in the delivery configuration, the first armand second arm can overlie each other along or adjacent to the centrallongitudinal axis of the body. For example, the two arms can havescissor-like configuration to reduce the profile of the arms in thedelivery configuration, such as the configuration illustrated in FIGS.55A-B.

The nasal implants described herein can include one or more barbs toimprove tissue engagement. The barbs can be generally directed such thatimplant moves easily in the distal direction but not in the proximaldirection. For example, the barbs can project outward and towards theproximal end of the implant to provide resistance to migration in theproximal direction. In general, when the implant is pulled in theproximal direction, the forks can move apart and make withdrawal moredifficult. When the implant is pulled proximally, the barbs can alsoexpand to provide resistance to proximal movement. For example, whenbarbs are positioned on the interior of forks, the barbs can furtherengage the tissue as the implant is pulled in the proximal direction,making withdrawal even more difficult.

In some embodiments, the barbs have a notch or tooth configuration. Thebarbs can be adapted to facilitate tissue in-growth when the implant isengaged with a portion of a nasal tissue of a patient.

In one example, the implants with the barbs can be made by molding theimplant with a protrusion and can then cutting the protrusion aftermolding to form the hinge. In another example, the barbs can be formedby skiving. In one example, the barbs can be formed by a living hingedesigned to fold out after deployment, such as the configuration of FIG.36. In another example, barbs can be formed with a small cut or slit inthe exterior of the implant.

In some embodiments, the barbs extend from the central body of theimplant. The barbs can each have a complementary shape to a plurality ofopenings on the central body such that, when the nasal implant is in thedelivery configuration, the barbs are engaged with the openings on thecentral body and thus flush with the central body. The barbs can extendfrom opposing surfaces of the central body portion. In some embodiments,the barbs on the opposing surfaces of the central body portion have astaggered configuration along the central body portion.

In some embodiments, the barbs extend from the distal end of the body ofthe implant. For example, barbs can extend from the first arm and secondarm. The barbs can extend from an outer surface of the first arm and anouter surface of the second arm away from the central longitudinal axisof the body or the plurality of barbs can extend from an inner surfaceof the first arm and an inner surface of the second arm towards thecentral longitudinal axis of the body. In some embodiments, the barbscan be staggered on the interior of the arms so that they do not add tothe diameter of the implant in the delivery configuration. For example,the barbs can be offset like scissors to allow for use with a smallercannula or delivery device.

In some embodiments, the plurality of barbs extend in line or parallelwith a plane formed by the first arm and the second arm in the deployedconfiguration. In some embodiments, the plurality of barbs extendtransversely to a plane formed by the first arm and the second arm inthe deployed configuration. Barbs can also extend in other orientationsrelative to the implant as well.

In some embodiments, the nasal implants described herein can include aplurality of openings to facilitate tissue ingrowth after the implant isdeployed in the patient. The openings can be, for example, in thecentral body portion or the arms.

A number of different examples and modifications of implants aredescribed herein. Features of any embodiment can be combined orsubstituted with features of any other embodiment.

The implants described herein can have modified stiffness and/orflexibility to provide the desired characteristics along various planes,axes, and/or locations.

FIGS. 3A-3B shows an implant 332 with modified stiffness having acentral body 338, an atraumatic proximal end 334, and a distal end 336with two forked arms 340, 342. Longitudinal grooves 333 extend along thelength of the central body 338 to preferentially make the nasal implantless stiff in one plane and more stiff in another. As used herein,stiffness, k, can be defined as the extent to which the implant resistsdeformation in response to an applied force, k=F/δ where F is the forceapplied on the body and δ is the displacement produced by the force.FIGS. 4A-4C illustrate the relationship between the cross-sectionalprofile of a material and the moment of inertia. For a rectangularmaterial the moment of inertia (Ix) can be represented as:I_(x)=(bh³)/12. For oval cross-sections, the moment of inertia can berepresented by I_(x)=πr⁴/4. For an annular material, the moment ofinertia can be represented as I_(x)=π(r_(o) ⁴−r₁ ⁴)/4. With the momentof inertia correlating to multiple powers of the cross-sectionaldimensions, small changes in the cross-sectional dimensions, such as theuse of grooves 333, can have a large effect on the moment of inertia andtherefore the stiffness.

FIGS. 5A-5B illustrate a nasal implant 532 having a central body 538, anatraumatic proximal end 534, and a distal end 536 with two forked arms540, 542. The central body 538 includes a tapered cross-section (asshown in FIG. 5B) with a diameter that decreases from the distal end 536to the proximal end 534, providing increased stiffness at the distal end536 relative to the proximal end 534.

FIG. 6 illustrates a nasal implant 632 having a central body 638, anatraumatic proximal end 634, and a distal end 636 with two forked arms640, 642. Multiple through-holes 666 extend along the longitudinal axis661 of the central body 638. In some embodiments, the holes 666 candecrease in diameter from the distal end 636 towards the proximal end634. The through-holes 666 can reduce the stiffness of the implant 632in certain directions and improve tissue ingrowth.

FIGS. 7A-7D illustrate embodiments of nasal implants with differentsurface modifications and cross-sectional shapes. As shown in FIG. 7A,nasal implant 732 a can have a central body 738 a, an atraumaticproximal end 734 a, and a distal end 736 a with two forked arms 740 a,742 a. The central body 738 a can have a smooth tapered cross-sectionthat decreases from the distal end 736 a to the proximal end 734 a. Asshown in FIG. 7B, a nasal implant 732 b can have a central body 738 b,an atraumatic proximal end 734 b, and a distal end 736 b with two forkedarms 740 b, 742 a. The central body 738 b can have a plurality ofundulations 777, such as ribs or scallops, extending circumferentiallyaround the central body 738 b. The frequency of the undulations 777 canincrease from the distal end 736 b to the proximal end 734 b. The higherfrequency of the undulations 777 can increase the flexibility of thenasal implant closer to the proximal end 734 b. As shown in FIG. 7C,nasal implant 732 c can have a central body 738 c, an atraumaticproximal end 734 c, and a distal end 736 c with two forked arms 740 c,742 c. The central body 738 c can have step changes in cross-sectionalarea such that the area decreases from the distal end 736 c to theproximal end 734 c, thereby reducing the stiffness at the proximal end734 c. As shown in FIG. 7D, a nasal implant 732 d with a central body738 d and two arms 740 d, 742 d can have a series of splines 771,grooves, or notches in the central body 738 d to vary and/or reducestiffness.

FIGS. 8A-8B illustrate additional embodiments of nasal implants. Asshown in FIG. 8A, a nasal implant 832 a can have a central body 838 a,an atraumatic proximal end 834 a, and a distal end 836 a with two forkedarms 840 a, 842 a. The central body 838 a can have a curve along thelongitudinal axis thereof. Thus, the forked distal end 836 a can beadapted to overlie the nasal bone, the curved central body 838 a can beadapted to overlie the upper lateral cartilage (ULC), and the proximalend 834 a can be adapted to engage with the lower lateral cartilage(LLC) to stent open or add support to the nasal valve. As shown in FIG.8B, a nasal implant 832 b can have a central body 838 b, an atraumaticproximal end 834 b, and a distal end 836 b with two forked arms 840 b,842 b. The central body 838 b can have tissue ingrowth features 888,such as webs or flaps. In some embodiments, the tips of the features 888can be annular and/or hollow. The ingrowth features 888 can allow rapidtissue ingrowth when the implant 832 b is implanted into the body.Further, the stiffness of the implants 832 a,b can be tailored byremoving material form certain locations of the implant.

FIGS. 9A-9C illustrate additional embodiments of nasal implants. Asshown in FIG. 9A, a nasal implant 932 a can have a central body 938 a,an atraumatic proximal end 934 a, and a distal end 936 a with two forkedarms 940 a, 942 a. The central body 938 can have a first through-hole999 a therein near the distal end 936 a and a second through-hole 999 btherein near the proximal end. In some embodiments, an open slit or holecan extend between the holes 999 a,b. In other embodiments, the holes999 a,b can be used to create tension with sutures. In some embodiments,a different material can be overmolded through the holes 999 a,b andbetween the holes 999 a,b. Referring to FIGS. 9B and 9C, in someembodiments, the nasal implants can have a composite structure. As shownin FIG. 9B, the central body 938 b can have a first material 993 b canbe layered between a second material 995 b. The first material 993 b canbe stiffer than the second material 995 b. As shown in FIG. 9B, thelayer of first material 993 b can be rectangular or flat and can extendin the same plane 992 b as the two arms of the implant. As shown in FIG.9C, in some embodiments, the first material 993 c (e.g., the stiffermaterial) can be in an hourglass-shape between the second material 995c. In some embodiments, the second material 995 b,c can be configured todegrade more quickly than the first material 993 b,c.

FIGS. 10A-10B illustrate embodiments of nasal implants made of acomposite structure. As shown in FIG. 10A, a nasal implant 1032 a canhave a central body 1038 a, an atraumatic proximal end 1034 a, and adistal end 1036 a with two forked arms 1040 a, 1042 a. The implant 1032a can further include a central core 1010 a extending the length of theimplant (e.g., along the longitudinal axis) that is filled with or madeof a different material than the rest of implant 1032 a. For example,the central core 1010 a can be a core pin material that includesdirectionally oriented fibers or a stiffer material insertedtherethrough. The stiffness of the implant 1032 a can be varied byselecting a desired core material with the desired stiffness. As shownin FIG. 10B, in some embodiments, the core 1010 b can wrap around and/orthrough the central portion 1038 b at an angle. The position and angleof the core 1010 b can vary the stiffness of the nasal implant 1032 b.

FIG. 17 illustrates a nasal implant with a stiffness that varies alongthe central longitudinal portion of the implant. The implant 1732 canhave a central body 1738, an atraumatic proximal end (not shown), and adistal end 1736 with two forked arms 1740, 1742. The central body 1738can have a proximal portion 1771 and a distal portion 1772 of differingstiffnesses. The proximal portion 1771 can be solid while the distalportion 1772 can have a pattern thereon. The patterned distal portion1772 can include material removed from the central body 1738. If thepatterned section consists of material that is removed or etched fromthe central body 1738, then the stiffness of distal portion 1772 wouldbe decreased relative to the stiffness of proximal portion 1771. In somecases, the patterned section can have material molded along thepatterned area to create a thickness that is greater than the thicknessD at other portions of the implant. The overmolded or increasedthickness of the pattern can increase the stiffness of portion 1772 ascompared to the stiffness of portion 1771. In some cases, the overmoldedmaterial can be a different material than the bulk of the nasal implant1732. Thus, a composite implant could be used having two or moredifferent materials. The material for the patterned portion of the nasalimplant 1732 can be selected to achieve a desired stiffness and/ordegradation rate of the implant 1732.

FIG. 18 illustrates the central body of a nasal implant withpreferential stiffness having a combination of grooves and barb likefeatures. The central body 1838 has a flattened shape with diagonalgrooves 1818 extending through. The angle of the diagonal grooves 1818can form sharp barbs 1881 on the edge of the elongate body 1838. Theillustrated central body 1838 can have maximum stiffness in the planeparallel to the forks/arms of the nasal implant while increasing theflexibility in the plane perpendicular to the forks/arms. The grooves1818 and barbs 1881 can also reduce the likelihood of migration of thenasal implant and improve tissue ingrowth.

FIG. 19 illustrates a nasal implant with modified stiffness along atleast one axis. The implant 1932 can have a central body 1938, anatraumatic proximal end 1934, and a distal end 1936 with two forked arms1940, 1942. The central body 1938 has a flattened shape with a series ofscalloped features 1919 along the edges. The scalloped features 1919 canreduce stiffness of the implant along one axis, such as the axisparallel to the plane of the arms 1940, 1942. The scalloped features1919 can also reduce the likelihood of migration of the nasal implant.

FIG. 21 illustrates a nasal implant with modified stiffness. The implant2132 can have a central body 2138, an atraumatic proximal end 2134, anda distal end 2136 with two forked arms 2140, 2142. Further the centralbody 2138 can have a central core 2192, for example a poly-L-lactide(PLLA) core, with an overmolded pattern thereover. The pattern caninclude barbs 2193 and grooves 2194 therebetween. The barbs 2193 can becompressible relative to the core 2192. The central body 2138 canarticulate or bend at the grooves 2194 until the gaps between adjacentbarbs (i.e., the grooves) are closed and adjacent barbs 2193 are incontact with one another. When the adjacent barbs 2193 are in contactwith one another, then the stiffness of the nasal implant 2132 greatlyincreases. The overmolded design of the implant 2132 allows for multiplematerials to be used with different physical properties and degradationrates.

FIGS. 22A-22C illustrate another nasal implant with modified stiffness.The nasal implant 2232 can have a central body 2238, an atraumaticproximal end 2234, and a distal end 2236 with two forked arms 2240,2242. The central body 2238 has non-uniform axial thickness including acore 2299 and a plurality of segments 2296 extending thereover. Thesegments 2296 can have grooves 2297 or gaps therebetween. The centralbody 2238 can flex until the gaps between adjacent segments 2296 closes.The grooves 2297 thus allow for some articulation or reduced stiffnessin some directions. The implant 2232 can remain in an elasticdeformation region where the effective diameter is more slender when alarge deflection forces the implant to bend to close the gap betweenadjacent segments 2296. Once the gap closes, the stiffness can increasesignificantly to prevent or reduce further bending.

FIG. 23 illustrates another nasal implant with modified stiffness. Thenasal implant 2332 can have a central body 2338, an atraumatic proximalend 2334, and a distal end 2336 with two forked arms 2340, 2342. Thecentral body 2338 includes linked conical-shaped segments 2397 that canaid in flexibility of the body 2338. Further, the proximal ends of thesegments 2397 can have barbs extending therefrom to improve tissueengagement and reduce migration of the implant.

FIGS. 24A-24B illustrate another nasal implant with modified stiffness.The nasal implant 2432 can have a central body 2438, an atraumaticproximal end 2434, and a distal end 2436 with two forked arms 2440,2442. The central body 2438 can have a laser cut cylindrical patternthereon. Laser cutting can facilitate the formation of unique geometriesfor the nasal implant 2432 with tailored physical properties, such asaxial compression and stiffness. The illustrated pattern allows foraxial compression without losing the bending ability of the cylindricalcentral body 2238 of the nasal implant 2432.

FIG. 25 illustrates another nasal implant with modified stiffness. Thenasal implant 2532 can have a central body 2538, an atraumatic proximalend 2534, and a distal end 2536 with two forked arms 2540, 2542. Thecentral body 2538 is cylindrical with a helical grooved scallop 2552running therearound that can increase the flexibility of the centralbody 2538.

FIGS. 26A-26F illustrate additional nasal implants having central bodieswith different patterns and different textures for modified stiffness.For example, the implant 2632 a of FIGS. 26A-26B has a central body 2638a, an atraumatic proximal end 2634 a, and a distal end 2636 a with twoforked arms 2640 a, 2642 a. The central body 2638 a is smooth withoutany ribs except for a transitional area 2662 a near the proximal end2634 a. The transitional area 2662 a includes a stepped tapered sectionand a series of grooves that contribute to the flexibility of theproximal portion of the implant 2632 a. The implant 2632 b of FIGS.26C-26D has a central body 2638 b, an atraumatic proximal end 2634 b,and a distal end 2636 b with two forked arms 2640 b, 2642 b. The centralbody 2638 b has a series of scallops 2666 b thereon that are configuredas smooth waves. The scallops 2666 b can provide increased flexibilityto the implant 2632. The implant 2632 c of FIGS. 26E-26F has a centralbody 2638 c, an atraumatic proximal end 2634 c, and a distal end 2636 cwith two forked arms 2640 c, 2642 c. The central body 2638 c has aseries of scallops 2666 c thereon. The scallops 2666 c are at a steeperangle than the scallops 2666 b and can provide flexibility to thecentral body 2638 c.

FIGS. 27A-F illustrate additional embodiments of nasal implants havingcentral bodies with different patterns and different textures formodified stiffness. For example, the implant 2732 a of FIGS. 27A-27B hasa central body 2738 a, an atraumatic proximal end 2734 a, and a distalend 2736 a with two forked arms 2740 a, 2742 a. The central body 2738 ahas two scalloped regions 2772 a,b separated by a central region 2773with a smooth outer surface. The scalloped regions 2772 a,b can provideflexibility towards the proximal and distal ends 2734 a, 2736 a whilemaintaining a stiffer central region 2773. The implant 2732 b of FIGS.27C-27D has a central body 2738 b, an atraumatic proximal end 2734 b,and a distal end 2736 b with two forked arms 2740 b, 2742 b. The implant2732 b is similar to implant 2732 a except that implant 2732 b includesthree scalloped sections 2774 a,b,c separated by two regions 2775 a,cwith smooth outer surfaces. The three scalloped sections 2774 a,b,c canprovide for increased flexibility relative to the two regions 2775 a,c.The implant 2732 c of FIGS. 27E-27F has a central body 2738 c, anatraumatic proximal end 2734 c, and a distal end 2736 c with two forkedarms 2740 c, 2742 c. The central body 2738 c includes a scalloped regionwhile the transition from the central body 2738 c to the proximal end2734 c is of smooth and of substantially constant diameter (rather thantapered as with many of the implant designs described herein), resultingin a stiffer proximal portion of the implant 2732 c.

FIGS. 34A-34B illustrate another nasal implant with modified stiffness.The nasal implant 3432 can have a central body 3438, an atraumaticproximal end 3434, and a distal end 3436 with two forked arms 3440,3442. The central body 3438 has flattened surfaces 3443 on two(opposite) sides and scalloped or ridged surfaces 3444 therebetween. Theflattened surfaces 3443 effectively reduce the thickness of the implant3432 along that dimension/axis, which can provide greater flexibilityfor the nasal implant about that axis. The nasal implant 3432 has aconstant thickness along the axis for flexing that can result indistributing the stress more uniformly when the implant flexes. In someembodiments, other configurations can be used, such as one flattenedsurface, more than two flattened surfaces, or flattened surfaces onadjacent sides.

FIGS. 28-33 illustrate various structures that can be used as thecentral body of the nasal implants described herein to provide thedesired stiffness and flexibility for that portion of the nasal implant.FIG. 28 illustrates a central body 2838 of a nasal implant with a closedpitch spiral shaft. FIG. 29 illustrates a central body 2938 of a nasalimplant with a uni-directional helix spiral shaft. FIG. 30 illustrates acentral body 3038 of a nasal implant with an open coil shaft, which cannot only increase flexibility, but also facilitate tissue ingrowthwithin the central body. FIG. 31 illustrates a central body 3138 of thenasal implant with a solid shaft and a spiral outer cut in the outersurface of the central body 3138. FIG. 32 illustrates a central body3238 of a nasal implant that includes a solid shaft having a dual,bi-directional spiral cut. FIG. 33 illustrates a central body 3338 of anasal implant that includes a bi-directional helix spiral shaft, whichcan not only increase flexibility, but also facilitate tissue ingrowthwithin the central body. In some embodiments, the chosen central bodyconfiguration can also tailor the degradation profile of the implant.

FIGS. 56A-56C illustrate a nasal implant with another embodiment of acentral body. The nasal implant 5632 can have a central body 5638, anatraumatic proximal end 5634, and a distal end 5636 with two forked arms5640, 5642. The central body 5638 can have a substantially constantrepeating and undulating pattern in an outer material over an inner corethat is tapered along the length of the core. Various taper angles canbe used with the inner core material to optimize the stiffness of theimplant and minimize stress during implant bending. Further, the tapercan start at different positions to minimize stress during implantbending. The taper angle, inner core configuration, and offsets can beselected to achieve a desired stiffness profile and stress profileduring implant bending.

FIGS. 57A-57D illustrate an embodiment of a nasal implant with amultiplane tapered configuration. The nasal implant 5732 includes acentral body 5738, an atraumatic proximal end 5734, and a distal end5736 with two forked arms 5740, 5742. The central body 5738 includes aflat taper in one plane, a tapered core in a second plane, and stressdistribution rib 5757 along a length of the implant in the first planetop and bottom of the implant. Additionally, a stress distribution rib5757 can be used along the flat taper to improve the stress distributionalong the length of the implant. The stress distribution rib 5757 can bealong multiple portions of the implant. In some cases, the stressdistribution rib 5757 can be used on opposing surfaces of the length ofthe implant. The stress distribution rib 5757 can have a discontinuousconfiguration. The illustrated stress distribution rib 5757 can have oneor more bearing feature 5775 therebetween. The bearing feature 5775 canfacilitate delivery tool interactions, such as delivery and deployment.A multitude of taper angles, starting taper offsets, and rib geometriescan be used to achieve a desired or pre-selected stiffness of theimplant while also minimizing the stress during bending. FIG. 57C is aside-profile view showing the right plane taper angle, and FIG. 57D is atop-down view showing the top plane tapered core angle.

FIGS. 58A-C illustrate an embodiment of a nasal implant with a generallytapered outer diameter. The nasal implant 5832 includes a central body5838, an atraumatic proximal end 5834, and a distal end 5836 with twoforked arms 5840, 5842. The central body 5838 has a taper along thelength thereof and a tapered inner core. The inner core and outermaterial can have a matching taper angle or different taper angles. Avariety of different taper angles can be used to achieve the desiredstiffness and bending properties of the implant. A multitude of taperangles and starting taper offsets can be used to achieve a desired orpre-selected stiffness of the implant while also minimizing the stressduring bending. The bearing features 5875 can facilitate delivery toolinteractions such as delivery and deployment. FIG. 58C shows the outerdiameter taper angle of the implant 5832.

In some embodiments, a treatment can be used to modify the properties ofthe exterior of the nasal implants described herein. For example, aplasma treatment on the surface of the nasal implant can imparthydrophilic properties to the implant. Plasma treatments can also beused to attach or adsorb functional groups to change the water ingressand therefore the degradation profile of the nasal implant. Further,plasma treatments can be used to crosslink polymers on the surface ofthe implant to preferentially change one or more of the degradationprofile, tissue response, tissue adhesion, and hydrophobicity of thenasal implant. The plasma treatment can also be used to modify thesurface of the nasal implant to act as a protective layer to the bulkbioresorbable material. As another example, plasma polymerization can beused to deposit a higher molecular weight layer on a nasal. Plasma canbe used to attach functional polymers or end groups onto plasmaactivated surfaces of the implant. In some embodiments, the plasmatreatment can be used to prepare a surface of the nasal implant for acoating, such as a parylene coating, to enhance adhesion between aninterior bioresorbable polymer and the parylene coating.

FIG. 11 illustrates a nasal implant 1132 having a central body 1138, anatraumatic proximal end 1134, and a distal end 1136 with two forked arms1140, 1142. The implant 1132 can have a non-contiguous coating, such asa coating of parylene, on the exterior thereof that can be used to tunethe degradation profile of the implant 1132. In some embodiments, thecoating can cover all of the implant 1132 except an opening 1111 at theproximal end 1134. The opening can allow fluid ingress to facilitate thedegradation of the implant 1132. FIG. 12 illustrates an exemplary methodof creating the opening 1111. As shown, a delivery tool 1200 can includea needle 1212 therein. The needle 1212 can be used to puncture theproximal end 1134, thereby puncturing the exterior coating and therebytuning the degradation of the implant 1132.

In some embodiments, the nasal implants described herein can be modifiedto reduce the likelihood of implant ejection, migration, and motion inthe first few weeks after implantation by promoting tissue ingrowth. Forexample, a treatment, such as a plasma treatment, can be applied to theouter surface of the implant to reduce the likelihood of implantejection, migration, and motion during the implantation of the nasalimplant. As another example, the implant can have hollow sectionsconfigured to provide for tissue ingrowth. As another example, barbs orwings that unfold can be used to dig into tissue and/or promote tissueingrowth.

If barbs are used, the barbs can have varying geometries andconfigurations, such as any of the barbs disclosed herein. The barbs canimprove the nasal implant's engagement with the tissue afterimplantation as well as improve tissue ingrowth. The barbs can havevarying sizes. In some embodiments, the barbs can be tiny and canimprove tissue engagement to prevent withdrawal of the nasal implantafter implantation. The nasal implants can be configured to be insertedthrough a portion of the upper lateral cartilage, inserted lateral to oron top of the upper lateral cartilage or to be inserted underneath theupper lateral cartilage. Features of the nasal implants in the expandedconfiguration post implantation can hold the rotational alignment of thenasal implant so that the stiffness and flexibility along differentplanes of the implant are somewhat fixed relative to the nasal anatomyand that the desired level of support is applied to the nasal valve.

The barbs can be configured to engage with soft tissue overlaying bonytissue proximal to the upper lateral cartilage. In some embodiments, aportion of the implant can be configured to engage with the upperlateral cartilage of the patient when the plurality of barbs are engagedwith the soft tissue overlying the bony tissue proximal to the upperlateral cartilage.

Any barbs on the nasal implant can be designed such that the barbs canhave a compressed delivery configuration within a cannula of thedelivery tool and then fold out or expand after the nasal implant isdelivered to the tissue to engage a portion of the targeted anatomy. Thebarbs can generally extend away from the forked end of the implanttowards the proximal end or atraumatic end of the implant to preventtissue migration.

The barbs can have different sizes and configurations. In some cases,the length of the barb can be expressed relative to a diameter of aportion of the implant. For example, the diameter of the portion of theimplant can correspond to the diameter of the central longitudinalportion of the implant. For embodiments of the nasal implants withvarying diameter along an axial length of the central longitudinalportion, the largest diameter of the central longitudinal portion can beused. In some cases, the diameter can correspond to the diameter of theimplant in the compressed delivery configuration, such as when the nasalimplant is within the cannula of the delivery device. In someembodiments, the barb has a length such that it extends from the surfaceof the nasal implant by a distance that is less than about 90% of thediameter of the portion of the implant. In some embodiments, the barbhas a length such that it extends from the surface of the nasal implantby a distance that is less than about 80% of the diameter of the portionof the implant. In some embodiments, the barb has a length such that itextends from the surface of the nasal implant by a distance that is lessthan about 70% of the diameter of the portion of the implant. In someembodiments, the barb has a length such that it extends from the surfaceof the nasal implant by a distance that is less than about 60% of thediameter of the portion of the implant. In some embodiments, the barbhas a length such that it extends from the surface of the nasal implantby a distance that is less than about 50% of the diameter of the portionof the implant. In some embodiments, the barb has a length such that itextends from the surface of the nasal implant by a distance that is lessthan about 40% of the diameter of the portion of the implant. In someembodiments, the barb has a length such that it extends from the surfaceof the nasal implant by a distance that is less than about 30% of thediameter of the portion of the implant. In some embodiments, the barbhas a length such that it extends from the surface of the nasal implantby a distance that is less than about 25% of the diameter of the portionof the implant. In some embodiments, the barb has a length such that itextends from the surface of the nasal implant by a distance that is lessthan about 20% of the diameter of the portion of the implant. In someembodiments, the barb has a length such that it extends from the surfaceof the nasal implant by a distance that is from about 5% of the diameterof the portion of the implant to about 90% of the diameter of theportion of the implant. In some embodiments, the barb has a length suchthat it extends from the surface of the nasal implant by a distance thatis from about 25% of the diameter of the portion of the implant to about40% of the diameter of the portion of the implant. In some embodiments,the barb has a length such that it extends from the surface of the nasalimplant by a distance that is from about 5% of the diameter of theportion of the implant to about 10% of the diameter of the portion ofthe implant.

An exemplary implant with anchoring features is shown in FIG. 13. Theimplant 1332 includes a central body 1338, an atraumatic proximal end1334, and a distal end 1336 with two forked arms 1340, 1342. The implant1332 further includes a suture 1313 extending from the arms 1340, 1342(e.g., attached to the arms 1340, 1342 with eyelets 1331 a,b). Thesuture 1313 can be pulled proximally to force the forked arms 1340 intoengagement with the tissue. In some embodiments, the implant 1332 canhave living hinges that are deployed by pulling on the suture 1313 toaid in anchoring.

Another exemplary implant with anchoring features is shown in FIG. 14.The implant 1432 includes a central body 1438 having a patterned surface1414 thereon. The patterned surface 1414 includes some open spaces thatcan allow for tissue ingrowth or engagement with the tissue.Additionally, the patterned surface 1414 can be used to modify thestiffness and mechanical properties of the nasal implant 1432. The outerpatterned surface 1414 can be connected to an inner core 1441 of thenasal implant 1432. The inner core 1441 configuration and material canbe selected to provide the desired stiffness and flexibility of theimplant 1432 along different planes.

Another exemplary implant with anchoring features is shown in FIG. 15.The implant 1532 includes a central body 1538 and a distal end 1536 withtwo forked arms 1540, 1542, and an atraumatic proximal end (not shown inFIG. 15). The central body 1538 can include a series of undulations 1515with hollow sections 1551 therein. The undulations 1515 and hollowsections 1551 can extend along the length of the nasal implant 1532. Thehollow sections 1551 allow tissue ingrowth along the length of theimplant 1538. Further, the undulations 1515 can extend on opposite sidesof the implant with flattened or substantially smooth surfacestherebetween. The undulations 1515 can thus provide a higher stiffnessin some planes compared to other planes. The nasal implant 1532 canprovide improved support of the nasal valve tissue by providing a higherstiffness to support the nasal valve tissue while providing lowerstiffness/more flexibility along other planes.

Another exemplary implant with anchoring features is shown in FIG. 16.The implant 1632 includes central body 1638, a distal end 1636 with twoforked arms 1640, 1642, and an atraumatic proximal end (not shown). Thecentral body 1638 includes a repeating exterior surface pattern withsections 1665 having a larger cross-section and barbs 1616 projectingtherefrom (e.g., on opposing sides of the central body 1638) andsections 1664 having a smaller cross-section than sections 1665 (e.g.,creating divots in the surface). The barbs 1616 within sections 1665 canimprove tissue engagement and reduce or prevent migration of the nasalimplant. Further, sections 1664 can improve the flexibility of the nasalimplant due to their smaller cross-section.

FIGS. 35A-35C illustrates a nasal implant with barbs configured to helpwith anchoring of the implant. The implant 3532 includes a central body3538, a distal end 3536 with two forked arms 3540, 3542, and anatraumatic proximal end (not shown). The arms 3540, 3542 can both havebarbs 3535 a,b thereon. Further, the barbs 3535 a,b can extend on theinner portions of the arms 3540, 3542 such that the barbs 3535 a on onearm 3540 point towards the barbs 3535 b on another arm 3542. The barbs3535 a can be staggered relative to the barbs 3535 b such that, uponcollapsing of the implant 3532 (e.g., during delivery), as shown inFIGS. 35B and 35C, the barbs 3535 a,b do not overlap to allow for a lowdelivery profile.

FIG. 36 illustrates another nasal implant with a plurality of barbs foranchoring. The nasal implant 3632 includes a central body 3638, a distalend 3636 with two forked arms 3640, 3642, and an atraumatic proximal end3634. The central body 3638 includes barbs 3635 thereon that aredesigned to fold out from the central body 3638 to prevent migration ofthe nasal implant 3632 after implantation. The foldable barbs 3635 canalso promote tissue ingrowth and spread the load for supporting thenasal valve tissue. The barbs 3635 illustrated in FIG. 36 are cut from aportion of the central body 3638 of the nasal implant such that thebarbs 3635 have a complementary structure to the corresponding recessesalong the body of the central body 3638. Additionally, the atraumaticproximal end 3634 includes two parallel features with atraumatic ends.The space between the features can advantageously allow for tissueingrowth.

FIG. 37 illustrates another nasal implant with a plurality of barbs foranchoring. The implant 3732 includes a central body 3738, a distal end3736 with two forked arms 3740, 3742, and an atraumatic proximal end3734. The nasal implant 3732 includes a plurality of barbs 3735projecting from opposing sides of the central body 3738 of the nasalimplant. The illustrated barbs 3735 have different sizes along the axisof the central body 3738. The lengths of the barbs 3735 increase withdistance from the forked end of the nasal implant. The barbs 3735 canalso project at varying angles with respect to the axis of the centralbody 3738. The barb configuration illustrated in FIG. 37 providesadditional surface area to support the tissue along with a largerfootprint to spread out the support for the nasal valve. The illustratedconfiguration also provides additional torsional resistance to twistingof the implant 3732 in the tissue.

FIG. 38 illustrated another nasal implant with a plurality of barbs foranchoring. The implant 3832 includes a central body 3838, a distal end3836 with two forked arms 3840, 3842, and an atraumatic proximal end3834. The central body 3838 includes a plurality of barbs 3835 along thelength thereof. The illustrated configuration has two barbs 3835projecting from each of two opposing sides of the nasal implant. Thebarbs 3835 are staggered along the length of the central body 3838.Further, the central body has a plurality of recesses 3883 adjacent to,and having a shape correspond to, each of the barbs 3835 so that thebarbs 3835 can have a compressed configuration for when the nasalimplant 3832 advances through the cannula for delivery to the targetedtissue.

FIGS. 39A-39D show two more embodiments of implants with barbedanchoring features. Referring to FIGS. 39A-39B, the implant 3932 aincludes a central body 3938 a, a distal end 3936 a with two forked arms3940 a, 3942 a, and an atraumatic proximal end 3934 a. The barbs 3935 acan be configured as small nubs that extend outwards from each of thearms 3942 a,b. Referring to FIGS. 39C-39D, the implant 3932 b includes acentral body 3938 b, a distal end 3936 b with two forked arms 3940 b,3942 b, and an atraumatic proximal end 3934 b. The arms 3940 b, 3942 binclude large barbs 3935 b extending therefrom. Each barb 3935 b caninclude a corresponding recess 3983 b configured to hold the barb 3935 btherein when the implant 3932 b is compressed.

FIGS. 40A-40B illustrate another implant with anchoring features. Theimplant 4032 includes a central body 4038, a distal end 4036 with twoforked arms 4040, 4042, and an atraumatic proximal end 4034. One or bothof the arms 4040, 4042 can include small notches 4004 on the outersurface thereof that can act as anchoring features. The notches 4004 canbe molded or skived. Further, the central body 4038 can include a seriesof raised rings 4005 therearound that can act as anchoring features.

FIGS. 41A-41B illustrate another implant with anchoring features. Theimplant 4132 includes a central body 4138, a distal end 4136 with twoforked arms 4140, 4142, and an atraumatic proximal end 4134. The arms4142, 4140 can include a plurality of transverse notched projections4141 thereon, e.g., configured as teeth. The projections 4141 can extendon both the top and bottom surfaces of each of the arms 4142. Further,the transverse projections can be molded or skived. Additionally, thecentral body 4138 can include a series of raised rings 4105 therearoundthat can act as anchoring features.

FIGS. 42A-42B illustrate another implant with anchoring features. Theimplant 4232 includes a central body 4238, a distal end 4236 with twoforked arms 4240, 4242, and an atraumatic proximal end 4234. The implant4232 includes a barb 4235 extending outwards from each of the externalsurfaces of the arms 4240, 4242. Additionally, the central body 4238 caninclude a series of raised rings 4205 therearound that can act asanchoring features.

FIGS. 43A-43B illustrate a nasal implant with anchoring features. Theimplant 4332 includes a central body 4338, a distal end 4336 with twoforked arms 4340, 4342, and an atraumatic proximal end 4334. The implant4332 includes two barbs 4335 at the portion of the implant where thearms 4340, 4342 meet the central body 4338. The barbs 4335 extendtransversely to the plane defined by the forked arms 4342, 4340. Thebarbs 4335 extend from two opposing sides of the implant and can bemolded or skived. Additionally, the central body 4338 can include aseries of raised rings 4305 therearound that can act as anchoringfeatures.

FIGS. 44A-44B illustrate another nasal implant with anchoring features.The implant 4432 includes a central body 4438, a distal end 4436 withtwo forked arms 4440, 4442, and an atraumatic proximal end 4434. Theimplant 4432 includes two barbs 4435 at the portion of the implant wherethe arms 4440, 4442 meet the central body 4438. The barbs 4435 extend inline with a plane defined by the forked arms 4442, 4440. The barbs 4435extend from two opposing sides of the implant and are molded.Additionally, the central body 4438 can include a series of raised rings4405 therearound that can act as anchoring features. There can be, forexample, 28-32 rings 4405, such as 30-31 rings, such as 30.5 rings. Eachring 4405 can create a valley that is approximately 0.004 inches deep.Further, the central body 4438 with the rings 4405 can be 0.5″-0.6″long, such as 0.55″ long. A diameter of the central body 4438 can beapproximately 1 mm. Further, the implant 4432 can include a smooth neck4448 at the distal end 4436 that is, for example, 0.020 to 0.025 incheslong, such as approximately 0.24 inches long. Finally, the implant 4432can include a smooth tail 4449 at the proximal end 4434 that does notinclude rings 4405 and is approximately 0.18″-0.20″, such as 0.19 incheslong. The tail can include a bulbous atraumatic end.

FIGS. 60A-60B illustrate a nasal implant 6032 that is similar to implant4432 except that the barbs 6035, in contrast to the barbs 4435, areskived. The implant 6032 thus includes a central body 6038, a distal end6036 with two forked arms 6040, 6042, and an atraumatic proximal end6034. The implant 6032 includes two barbs 6035 at the portion of theimplant where the arms 6040, 6042 meet the central body 6038.

FIGS. 45A-45B illustrate another nasal implant with anchoring features.The implant 4532 includes a central body 4538, a distal end 4536 withtwo forked arms 4540, 4542, and an atraumatic proximal end 4534. Theimplant 4532 includes a plurality of barbs 4535 extending on the outerside of each arm 4542, 4540. The barbs 4535 can be projections formed asjagged pointed teeth and can be molded or skived. Additionally, thecentral body 4538 can include a series of raised rings 4505 therearoundthat can act as anchoring features.

FIGS. 46A-46B illustrate a nasal implant that is similar to implant4532. The implant 4632 thus includes a central body 4638, a distal end4636 with two forked arms 4640, 4642, an atraumatic proximal end 4634,and a plurality of barbs 4635 configured similarly to the barbs inimplant 4532 except that the barbs sit in a grooved window 4646 oropening in the outer surface to both improve the compactness of theimplant when compressed and to help improve tissue ingrowth.

FIGS. 47A-47B illustrate another implant with anchoring features. Theimplant 4732 includes a central body 4738, a distal end 4736 with twoforked arms 4740, 4742, and an atraumatic proximal end 4734. The implant4732 includes a plurality of smaller barbs 4735 extending from an insidesurface of each of the arms 4740, 4742. The smaller notch type barbs4735 extend from each of the arms 4740, 4742 towards the opposite arm.The smaller barbs 4735 are illustrated as jagged shark teeth typeprojections. The barbs 4735 can be molded or skived.

FIGS. 48A-48B illustrate another implant with anchoring features. Theimplant 4832 includes a central body 4838, a distal end 4836 with twoforked arms 4840, 4842, and an atraumatic proximal end 4834. The implant4832 includes a smaller barb 4835 extending from an inside surface ofeach of the arms 4840, 4842 towards the opposite arm 4840, 4842. Thebarbs 4835 are skived. Additionally, the central body 4838 can include aseries of raised rings 4805 therearound that can act as anchoringfeatures.

FIGS. 49A-49B illustrate another implant with anchoring features. Theimplant 4932 includes a central body 4938, a distal end 4936 with twoforked arms 4940, 4942, and an atraumatic proximal end 4934. The implant4932 includes smaller barbs 4935 extending from an inside surface ofeach of the arms 4940, 4942. The smaller barbs 4935 extend from each ofthe arms 4942, 4940 towards the other arm. The illustrated barbs 4935are molded with the body of the implant and then undercut. Additionally,the central body 4938 can include a series of raised rings 4905therearound that can act as anchoring features.

FIGS. 50A-50B illustrate another implant with anchoring features. Theimplant 5032 includes a central body 5038, a distal end 5036 with twoforked arms 5040, 5042, and an atraumatic proximal end (not shown). Theimplant 5032 includes two barbs 5035 at the portion of the implant wherethe forked end meets the central body of the implant. The barbs 5035extend in line with the plane defined by the arms 5042, 5040 of theimplant. The barbs 5035 extend from two opposing sides of the implant5032. The illustrated barbs 5035 are molded with the body of the implant5032 and then undercut. Additionally, the central body 5038 can includea series of raised rings 5005 therearound that can act as anchoringfeatures.

FIGS. 51A-51B illustrate another implant with anchoring features. Theimplant 5132 includes a central body 5138, a distal end 5136 with twoforked arms 5140, 5142, and an atraumatic proximal end 5134. The implant5132 includes two barbs 5135 at the portion of the implant where theforked arms 5142, 5140 meet the central body 5138 of the implant. Thebarbs 5135 extend in line with the plane defined by the arms 5142, 5140of the implant. The barbs 5135 extend from two opposing sides of theimplant 5132. Further, in contrast to implant 5032, implant 5132 has anarrow or tapered section 5151 between the central portion 5138 and thedistal end 5136 over which the barbs 5135 extend. In one example, thebarbs 5135 can be molded inside of undercuts. Additionally, the centralbody 5138 can include a series of raised rings 5105 therearound that canact as anchoring features.

FIGS. 52A-52B illustrate another implant with anchoring features. Theimplant 5232 includes a central body 5238, a distal end 5236 with twoforked arms 5240, 5242, and an atraumatic proximal end 5234. The implant5232 includes two barbs 5235 at the portion of the implant where theforked arms 5242, 5240 meet the central body 5238 (and extend overnarrow section 5240). The barbs 5235 are longer and thinner than thebarbs of implant 5132. The barbs 5235 extend in line with the planedefined by the arms 5240, 5242 and extend from two opposing sides of theimplant 5232. The neck barbs 5235 can be molded inside of undercuts.Additionally, the central body 5238 can include undulations that canhelp to anchor the implant in the tissue.

FIGS. 59A-59B illustrate an embodiment of a nasal implant with one ormore barbs or barb features. The implant 5932 includes a central body5938, a distal end 5936 with two forked arms 5940, 5942, and anatraumatic proximal end 5934. The implant 5932 further includes barbs5935 between the distal tip of the distal end 5936 and the centralportion 5938. Different barb geometries can be used, such as varying thethickness of the barb at its base, the length of the barb, how far thebarb is offset from the implant surface and the thickness of the barbitself. Additionally, the barbs 5935 can be in any orientation planepositioned about the entire 360 degrees circumference of implant 5392.The dimensions and geometries of the barb can be designed to achieve adesired or pre-selected anchoring performance of the implant.

FIGS. 61A-61B illustrate a nasal implant 6132 with barbs 6135 at theportion of the implant where the forked arms 6142, 6140 meet the centralbody 6138. The barbs 6135 extend in line with the plane defined by the6140, 6142. The barbs 6135 extend from two opposing sides of theimplant. The barbs 6135 illustrated in FIG. 61 are molded with anundercut. As shown in FIG. 61C, the barbs 6135 can be angled at greaterthan 10 degrees, such as greater than 15 degrees relative to the neck ofthe distal end 6136. In other embodiments, the barbs are positionedrelative to the neck of the distal end (e.g., at an angle of 10-20degrees relative to the neck or at an angle of more than 20 degreesrelative to the neck). Additionally, the central body 6138 can include aseries of raised rings 6105 therearound that can act as anchoringfeatures. There can be, for example, 12-18 rings 6105, such as 15 rings6105. Further, the valley between the rings 6105 can increase in depthfrom the distal end 6136 to the proximal end 6134 (e.g., fromapproximately 0.0027″ to approximately 0.004″). The core of the centralportion 6138 can thus be tapered from the distal end 6136 to theproximal end 6134 (e.g., at a 5 degree taper). A diameter of the centralbody 6138 at the rings 6105 can be approximately 1 mm, and a length ofthe central body 6138 can be 0.5″-0.6″, such as approximately 0.55″.Further, the implant 6132 can include a smooth neck 6148 at the distalend 6136 that is approximately 0.02″-0.03″ long, such as 0.025″ long.The implant 6132 can include a smooth tail 6149 at the proximal end 6134that does not include rings 6105 and is approximately 0.15″-0.19″, suchas 0.18″ long. The tail can include a bulbous atraumatic end. The designof the implant 6132 can advantageously be optimized to reduce themaximum stress on the implant upon implantation.

FIG. 62 illustrates an example showing an axial cross-sectional viewthat includes compressed wings 6262 a,b having a sheet-likeconfiguration that can be used as part of the implants described hereinas anchoring features, e.g., to engage with tissue to prevent migration.The wings 6262 a,b can also increase stiffness in certain planes of theimplant.

In some embodiments, the nasal implant may not include forked arms. Forexample, FIG. 20A illustrates a nasal implant 2032 with a central body2038 and two rounded atraumatic ends 2034A,b instead of a single roundedatraumatic end and another end having arms or forks. FIG. 20Billustrates an example of how the nasal implant 2032 can be implantedrelative to the nasal anatomy to support the nasal valve. As shown inFIG. 20B, the nasal implant 2032 is implanted with one rounded end 2034a in the lower lateral cartilage (LLC) and the other rounded end 2034 bof the nasal implant is adjacent to the maxilla bone (MB).

In some embodiments, the forked arms of the implants can have sharpenededges.

For example, FIGS. 53A-53B illustrate an embodiment of a forked distalend 5336 of a nasal implant. Each of the arms 5342, 5340 of the distalend 5336 includes a sharp faceted tip that is sharpened to facilitatetissue piercing and separation for tissue in or adjacent to the nasaltissue, such as mucosa and cartilage. The faceted tip design shown inFIGS. 53A-53B can be used in any of the nasal implants described herein.The faceted tip design can be formed by molding a beveled cutting tipinto the fork tines. The facets are on the parting line plane of thepart thereby facilitating ease of molding. The design can improve thepiercing and slicing of soft tissue, which can reduce piercing andfixation forces used to deliver the implant to the targeted tissue. Theoutward angle of the bevels can also enhance the spreading of the armsfor the expanded configuration during deployment.

As another example, FIGS. 54A-54B illustrates an embodiment of a forkeddistal end 5436 of a nasal implant. Each arm 5442, 5440 includes afaceted tip having a 30 degree angle cut, which can help reduce piercingforce. The faceted tip design shown in FIGS. 54A-54B can be used in anyof the nasal implants described herein. The design shown in FIGS.54A-54B can be formed by cutting the arm of the fork at a 30 degreeangle from the parting line plane in one direction. The cutting processcan cut off a portion of the bridge as well as the tines. In embodimentsthat use a circular cut made by a trimming fixture, the resulting tipsshown in FIG. 54 can form points with two flat facets and one roundedsurface. The single angle also provides the potential benefit of biasingthe direction of the arms 5440, 5442 towards the nasal bone, which canpotentially prevent the forks from piercing the patient's skin.

In some embodiments, the arms of the nasal implants can be axiallyoffset from one another.

For example, FIGS. 55A-55B illustrate an embodiment of a forked distalend 5536 of a nasal implant with axially offset arms 5540, 5542. Eacharm 5540, 5542 includes a faceted tip. Further, each of the arms 5540,5542 include a plurality of teeth 5535 projecting outward. The offsetarms 5540, 5542 can provide for a lower profile for the arms 5540, 5542when the implant 5532 is in a compressed configuration. The design shownin FIG. 55 can be formed by molding the fork arms 5540, 5542 in anoffset, scissor-like design, which enables the arms 5540, 5542 to foldcompletely inwards within the diameter of the implant profile. Byenabling the complete folding of the fork arms 5540, 5542, a pluralityof outward facing teeth can be added without adding to the overallprofile of the implant 5532 in the compressed configuration, as anincrease in the implant profile would increase drag within the cannula.The facets at the distal ends of the arms 5540, 5542 can also enhancepiercing into soft tissue.

In some embodiments, the nasal implants described herein can bedelivered to the targeted anatomy using a delivery tool with a hollowneedle or cannula. The delivery tool can pierce the patient anatomy tolocate the tip of the hollow needle or cannula adjacent to the targetedtissue. The hollow needle or cannula can be used to advance the nasalimplant in the delivery configuration (e.g. compressed configuration).The nasal implant can be placed by pushing the nasal implant out of theneedle, by withdrawing the needle relative to the implant, orcombinations thereof. The hollow needle or cannula can have anorientation feature, like a non-circular cross-section, to control theorientation of the nasal implant so that the expanded configuration ofthe first arm and second arm of the implant can be deployed with thedesired placement and orientation relative to the targeted tissue.Examples of delivery tools and delivery methods for orienting anddelivering the nasal implant to the targeted tissue are described inU.S. application Ser. No. 15/274,986 titled “Nasal Implants and Systemsand Method of Use” and U.S. 2016/0058556, the disclosures of each ofwhich are incorporated by reference in their entirety.

In some variations, the implants described herein can have a relativelylow profile (e.g., short height) in at least one dimension (length,width, height). The implant height can be, for example, less than 1 mm,less than 2 mm, less than 3 mm, less than 4 mm, less than 5 mm, lessthan 10 mm, less than 20 mm, or any size in between these, e.g., from 1mm to 2 mm, from 1 to 5 mm, from 2 mm to 4 mm, etc. A low profileimplant may be particularly beneficial, for example, because it may beinserted through a relatively small implant hole that heals easily, itmay be the desired shape to fit anatomy of the space into which it isimplanted, and/or it may not be obviously visible when implanted. Theimplant height may be chosen based on the implant environment anddesired effect of the implant. For example, in the face and nose,underlying cartilage and bone generally determine face and nose shape,though muscle and skin play a role as well. The muscle, skin andassociated tissues that cover the underlying cartilage and bone tend totake on the shape of the underlying structure that they cover. Skin andmuscle thickness vary between individuals. Some people have relativelythicker skin and muscle and others have thinner skin and muscle. Arelatively tall implant located over cartilage or bone may cause anobvious bump or protrusion in overlying thin muscle and skin that may benoticeable simply by looking at the person who may feel uncomfortable orself-conscious due to the attention, but may not cause an obvious bumpor protrusion in a person with thicker muscle and skin which may betteraccommodate or mask the implant. An implant with a relatively smallheight may create a relatively low profile that is not obvious throughthe skin when the implant is in place in the nose. A low profile implantmay, in some cases, make a small bump or protrusion that is detectableby close inspection or palpation. A body of the implant may be curved orbent (and may have various features that are not straight), but ingeneral can be relatively straight and able to bend or flex. Forexample, the implant may flex to a minimum bend radius of 15 mm+/−0.5mm.

An implant as described herein may be made of any biocompatible materialthat provides the desired support and shaping properties of the implant.The implant may be partially or wholly made from a non-biodegradablematerial as known in the art such as any polymer, metal, or shape memorymaterial. The implant may be made from organic and/or inorganicmaterials. The material of the implant may be solid, (e.g. titanium,nitinol, or Gore-tex), braided or woven from a single material (such astitanium, or Polyethylene Terephthalate, or a combination of materials).If made of a woven material, the woven material may have pores thatallow ingrowth of tissue after implantation. Representative syntheticpolymers include alkyl cellulose, cellulose esters, cellulose ethers,hydroxyalkyl celluloses, nitrocelluloses, polyalkylene glycols,polyalkylene oxides, polyalkylene terephthalates, polyalkylenes,polyamides, polyanhydrides, polycarbonates, polyesters, polyglycolides,polymers of acrylic and methacrylic esters, polyacrylamides,polyorthoesters, polyphe azenes, polysiloxanes, polyurethanes, polyvinylalcohols, polyvinyl esters, polyvinyl ethers, polyvinyl halides,polyvinylpyrrolidone, poly(ether ketone)s, silicone-based polymers andblends and copolymers of the above.

Specific examples of these broad classes of polymers include poly(methylmethacrylate), poly(ethyl methacrylate), poly(butyl methacrylate),poly(isobutyl methacrylate), poly(hexyl methacrylate), poly(isodecylmethacrylate), poly(lauryl methacrylate), poly(phenyl methacrylate),poly(methyl acrylate), poly(isopropyl acrylate), poly(isobutylacrylate), poly(octadecyl acrylate), polyethylene, polypropylene,poly(ethylene glycol), poly(ethylene oxide), poly(ethyleneterephthalate), poly(vinyl alcohols), poly(vinyl acetate), poly(vinylchloride), polystyrene, polyurethane, poly(lactic acid), poly(butyricacid), poly(valeric acid), poly[lactide-co-glycolide], poly(fumaricacid), poly(maleic acid), copolymers of poly (caprolactone) or poly(lactic acid) with polyethylene glycol and blends thereof.

A polymer used in the implants described herein may benon-biodegradable. Examples of non-biodegradable polymers that may beused include ethylene vinyl acetate (EVA), poly(meth)acrylic acid,polyamides, silicone-based polymers and copolymers and mixtures thereof.

In some embodiments, the implant can include one or more bioabsorbablematerials in combination with a non-absorbing material. For example, insome cases, at least one of the distal end, proximal end, or centralbody is composed of a core made of a non-absorbable or an absorbablematerial. The implant can then include an outer layer made of adifferent non-absorbable or absorbable material from the core. In someexamples, the core and outer layer are fixedly laminated to one another.In other examples, the core and outer layer are slid-ably engaged withone another.

In some embodiments, the first and second arms of the implant areconfigured to self-expand toward the deployed configuration. In someembodiments, the first and second arms of the implant are configured tomove to the deployed configuration through engagement with tissue orpart of the delivery tool.

For example, an implant or arms or features on an implant may includeshape memory material. In some variations, an implant includes abiocompatible, bioabsorbable material such as a bioabsorbable polymer. Abioabsorbable or biodegradable implant may provide structure and supportto a body tissue, such as nasal tissue, for a temporary period of timeand may induce or cause the formation of scar or other tissue thatprovides structure and support to the body tissue for a longer period oftime, including after the implant is degraded. Biologically formed scaror other tissue may be beneficial because it may be more comfortable,provide longer term support, stay in place better, etc. than does animplant. Part or all of an implant may be degradable in vivo (alsoreferred to as biodegradable) into small parts and may be bioabsorbable.An implant or implant body may consist essentially of a bioabsorbablematerial. An implant or implant body may include two or more than twodifferent bioabsorbable materials. A method as described herein mayinclude biodegrading and bioabsorbing an implant or just part of animplant if an implant includes both bioabsorbable and non-bioabsorbableparts. Bioabsorbing may be facilitated by tissues and organs. Tissuesand organs that bioabsorb may include bodily fluids, such as blood,lymph, mucus, saliva, etc. Bacteria may also aid in bioabsorbing amaterial. A n implant may be partially or wholly made from one or morebiocompatible biodegradable material, such as from a naturally occurringor synthetic polymer. A biodegradable implant may be made from apoly(lactide); a poly(glycolide); a poly(lactide-co-glycolide); apoly(lactic acid); a poly(glycolic acid); a poly(lactic acid-co-glycolicacid); poly(lactide)/poly(ethylene glycol) copolymers; apoly(glycolide)/poly(ethylene glycol) copolymers; apoly(lactide-co-glycolide)/poly(ethylene glycol) copolymers; apoly(lactic acid)/poly(ethylene glycol) copolymers; a poly(glycolicacid)/poly(ethylene glycol) copolymers; a poly(lactic acid-co-glycolicacid)/poly(ethylene glycol) copolymers; a poly(caprolactone);poly(caprolactone)/poly(ethylene glycol) copolymers a poly(orthoester);a poly(phosphazene); a poly(hydroxybutyrate) or a copolymer including apoly(hydroxybutyrate); a poly(lactide-co-caprolactone); a polycarbonate;a polyesteramide; a polyanhidride; a poly(dioxanone); a poly(alkylenealkylate); a copolymer of polyethylene glycol and a polyorthoester; abiodegradable polyurethane; a poly(amino acid); a polyetherester; apolyacetal; a polycyanoacrylate; a poly(oxyethylene)/poly(oxypropylene)copolymer, or a blend or copolymer thereof. In some examples, an implantincludes poly-L-lactic acid (PLLA)), poly-D-lactic acid (PDLA),poly-D,L-lactic acid (PLDLLA) or a combination of two. In some examples,an implant is 90:10, 80:20, 70:30, 60:40, 50:50 PLLA/PDLA copolymer oris in between any of these values. In some examples, an implant is70:30, +/−10% PLLA/PDLA copolymer. In some examples, an implant is70:30, +/−10% PLLA/PDLLA.

An implant as described herein may include additional materials, such asan antibiotic, another antibacterial agent, an antifungal agent, anantihistamine, an anti-inflammatory agent, a cartilage growth inducer, adecongestant, a drug, a growth factor, microparticles, a mucolytic, aradiopaque material, a steroid, a vitamin, etc. Such materials may beattached to, adhered to, coated onto, or incorporated into to animplant. Such materials may be inserted into a body tissue along withthe implant. Such materials may be required at different times and maybe time sensitive or time release. For example, an anti-inflammatoryagent may be useful immediately after implantation to prevent too muchearly inflammation and pain, but may not be desirable during laterstages of scar formation and healing as it may interfere with a healingprocess that provides new tissue to provide support for tissues once theimplant is remove. For example, an implant may be configured to releasea cartilage growth inducer, such as a fibroblast growth factor (FGF;such as basic fibroblast growth factor or FGF2) or a transforming growthfactor (TGF; such as TGFβ1) after several days or weeks so as to preventan inappropriate or unwanted response early on.

The implants disclosed herein can include multiple materials to tailorthe stiffness of the implant, outer hardness/softness, biocompatibility,and absorption profile of the implant. In some embodiments the implantscan include an inner structure that is degradable with an outer coatingthat is hydrophobic. The degradable material can degrade in vivo throughhydrolysis. Degradation can be slowed by coating the degradable materialwith a coating, such as a hydrophobic coating to control or tune thedegradation of the implant. The hydrophobic coating can delay ingress ofwater and subsequently delay hydrolysis of the degradable portion of theimplant. An example of a hydrophobic material that can be used ispolycaprolactone, which is an absorbable material that is hydrophobic,crystalline, and highly elastic making it well suited for a coating. Thecoating can be applied with a specifically selected blend of solvents tominimize the impact on the underlying polymer structure. In someembodiments, a non-absorbable biocompatible coating, such as a silicone,an epoxy acrylate, or Parylene™ could be used to slow the absorption ofwater into the underlying polymer.

The biodegradation rate, profile, and/or period of the implant can betuned. For example, a multitude of coatings both absorbable andnon-absorbable can be applied to an underlying implant structure thatalready exhibits the necessary mechanical properties for supportingupper and lower lateral nasal cartilage. Many possible coatings existincluding poly-caprolactone, silicone, fluoropolymers, vinyl alcohol,acrylates, etc. In some embodiments the coating can be Parylene™. Anexemplary hydrophobic coating compound, Parylene™(poly(dichloro-para-xylylene)) has the forms:

Parylene™ N is the basic member of the family and is typically mostpermeable to moisture. Parylene™ C and D are typically used for moisturebarrier properties. Existing forms of Parylene™ have been primarily usedas a complete moisture barrier for electronics and medical implants dueto typically pinhole free coating properties. In some cases Parylene™can be used as a control release agent for drugs being released out of amaterial below the coating. For example, the drug can be in a layer ormaterial beneath the Parylene™ coating. In other forms of coatings,Parylene™ can also be used for adding lubricious coatings on guidewiresand catheters. In the present disclosure Parylene™ is used differentlythan the traditional applications. In one embodiment, the semi-permeablenature of extremely thin coating layers can be used advantageously tocontrol water ingress through the thin coating and into contact with theunderlying implant structure. The biodegradation rate of the implant canbe controlled by selecting and controlling the thicknesses andconformality of the coating, such as a Parylene™ coating.

The conformal coating process for Parylene™ can allow for controllingthe thickness of the coat on the implant substrate. In order tofacilitate some water transmission through the Parylene™ coating andinitiate hydrolytic degradation, the implant may be coated atthicknesses in the range of about 0.1 to about 10 microns, preferably inthe range of 0.1 to 5 micron to allow for a semi-permeable design. Thedesign of a semi-permeable coat achieves selective tuning of theabsorption rate of the implant, where the extent of permeation isdetermined by the coating thickness and conformality.

The thickness of the hydrophobic coating can be selected to modify theabsorption profile of the implant. In some embodiments the thickness ofthe hydrophobic coating can be from about 0.1 micron to about 10microns. In some embodiments the thickness of the hydrophobic coatingcan be from about 0.1 micron to about 5 microns. In some embodiments thethickness of the hydrophobic coating can be from about 0.1 micron toabout 1 micron. In some embodiments the hydrophobic coating has athickness of less than 10 microns. In some embodiments the hydrophobiccoating has a thickness of less than 5 microns. In some embodiments thehydrophobic coating has a thickness of less than 1 micron. The thicknessof the coating can be selected to control the rate of water ingressthrough the coating and into the core of the implant.

The hydrophobic coating can be applied to the entire outer surface ofthe implant or portions of the outer surface of the implant. In someembodiments the hydrophobic coating is applied to a central rod portionof the implant. In another embodiment the hydrophobic coating is appliedto the implant except for the ends. For example, the proximal end or tipcan be uncoated to act as a site for water ingress.

The conformality of the hydrophobic coating can also be selected tomodify the absorption profile of the implant. In some embodiments, theconformality of the hydrophobic coating is selected to control the rateof water ingress through the hydrophobic coating and into the core ofthe implant. In some embodiments, the hydrophobic coating has apatterned conformality with coated sections and open sections. Thepatterned hydrophobic coating can be applied over the entire outersurface of the implant or on portions of the implant. In someembodiments the hydrophobic coating can have a porous structure.

In some embodiments the hydrophobic coating can have a laminatedstructure made out of multiple materials. For example, a combination ofbioabsorbable layers and non-bioabsorbable layers can be used in someembodiments to tune the degradation rate or profile of the implant afterimplantation in the nasal tissue. The coatings can be applied using avariety of processes, such as vapor deposition, dip coating, spraycoating, sputter coating, brush layering, etc.

In some embodiments, the hydrophobic coating is bioabsorbable. In thecase of polycaprolactone, the coating itself is hydrophobic andbioabsorbable allowing for complete resorption over time. Using a dipcoating method, a coating thickness of 0.1 to 10 microns can be achievedfor desired results. Additionally, the same effect can be achieved bydepositing 0.001 to 20 weight percent of polycaprolactone on the implantsubstrate. Polycaprolactone is dissolved readily in a mixture of varioussolvents consisting of but not limited to cycloalkanes, organic esters,chloroform and other such organic solvents.

The implants described herein can have an outer diameter of 0.5 mm-1.5mm, such as approximately 1 mm.

The degradation profile rate of the implants described herein can beselectively tuned such that the life of the implant core or implant basepolymeric substrate can be increased up to 20-fold.

In some embodiments, the delivery device used to implant the nasalimplants described herein can include a needle with a non-circularcross-section, such as an oval in one example, to accommodate tissueingrowth features and/or acute tissue attachment features of theimplant.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements, these features/elements should not be limitedby these terms, unless the context indicates otherwise. These terms maybe used to distinguish one feature/element from another feature/element.Thus, a first feature/element discussed below could be termed a secondfeature/element, and similarly, a second feature/element discussed belowcould be termed a first feature/element without departing from theteachings of the present invention.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. A nasal implant comprising: a central body havinga proximal end and a distal end; a first arm disposed at the distal end,the first arm having a proximal end fixed to the distal end of thecentral body and a distal end not fixed to the body, the distal end ofthe first arm being adapted to move away from a central longitudinalaxis of the central body from a delivery configuration toward a deployedconfiguration; a second arm having a proximal end fixed to the distalend of the central body and a distal end not fixed to the body, thedistal end of the second arm being adapted to move away from a centrallongitudinal axis of the central body from a delivery configurationtoward a deployed configuration; and a plurality of barbs on the implantconfigured to engage with tissue when the nasal implant is deployed. 2.The implant of claim 1, wherein the plurality of barbs extend from thecentral body.
 3. The implant of claim 2, wherein the plurality of barbsextend from the distal end of the central body and point towards theproximal end of the central body.
 4. The implant of claim 3, wherein theplurality of barbs extend at an angle of 15 degrees or greater relativeto the central body.
 5. The implant of claim 3, wherein there are twobarbs, and wherein the two barbs extend from opposing surfaces of thecentral body.
 6. The implant of claim 5, wherein there are a pluralityof barbs extending down each of the opposing surfaces, the plurality ofbarbs on each surface having a staggered configuration along the centralbody.
 7. The implant of claim 1, wherein the plurality of barbs extendfrom the first arm and second arm.
 8. The implant of claim 7, whereinthe plurality of barbs extend from an outer surface of the first arm andan outer surface of the second arm away from the central longitudinalaxis of the central body.
 9. The implant of claim 7, wherein theplurality of barbs extend from an inner surface of the first arm and aninner surface of the second arm towards the central longitudinal axis ofthe central body.
 10. The implant of claim 9, wherein the plurality ofbarbs on each arm have a staggered configuration.
 11. The implant ofclaim 1, wherein the plurality of barbs extend in line or parallel witha plane formed by the first arm and the second arm in the deployedconfiguration.
 12. The implant of claim 1, wherein the plurality ofbarbs extend transversely to a plane formed by the first arm and thesecond arm in the deployed configuration.
 13. The implant of claim 1,wherein the plurality of barbs each have a complementary shape to aplurality of openings on the central body or the first and seconds armsuch that, when the nasal implant is in the delivery configuration, theplurality of barbs are engaged with the openings on the central body orthe first and second arms.
 14. The implant of claim 1, wherein theplurality of barbs have a notch or tooth configuration.
 15. The implantof claim 1, further comprising a plurality of openings in the centralbody portion adapted to allow tissue ingrowth.
 16. The implant of claim1, further comprising a plurality of openings in the first and secondarms adapted to allow tissue ingrowth.
 17. The implant of claim 1,wherein the central body includes a hollow or open structure along acentral longitudinal axis of the implant.
 18. The implant of claim 1,wherein the central body includes a solid structure along a centrallongitudinal axis of the implant.
 19. The implant of claim 1, whereinthe central body comprises a closed pitch spiral configuration.
 20. Theimplant of claim 1, wherein the central body comprises a uni-directionalhelix spiral configuration.
 21. The implant of claim 1, wherein thecentral body comprises a bi-directional helix spiral configuration. 22.The implant of any of claim 1, wherein the central body comprises anopen coil configuration.
 23. The implant of claim 1, wherein the centralbody comprises a solid shaft with a spiral cut outer surface.
 24. Theimplant of claim 1, wherein the central body comprises a solid shaftwith a dual, bi-directional spiral cut outer surface.
 25. The implant ofclaim 1, further comprising a first faceted tip on the distal end of thefirst arm and a second faceted tip on the distal end of the second arm.26. The implant of claim 1, further comprising a first sharpened tip onthe distal end of the first arm and a second sharpened tip on the distalend of the second arm.
 27. The implant of claim 26, wherein the facetedtip or sharpened tip includes a surface formed from a planar cut at anangle of 45 degrees or less.
 28. The implant of claim 26, wherein thefaceted tip or sharpened tip includes a surface formed from a planar cutat an angle of 35 degrees or less.
 29. The implant of claim 26, whereinthe faceted tip or sharpened tip includes two or more surfaces formedfrom planar cuts.
 30. The implant of claim 1, wherein the first arm andthe second arm have an offset configuration such that, in the deliveryconfiguration, the first arm and second arm overlie each other along oradjacent to the central longitudinal axis of the body.
 31. The implantof claim 1, wherein the body consists essentially of a bioabsorbablematerial.
 32. The implant of claim 1, wherein at least one portion ofthe implant is composed of a bioabsorbable material.
 33. The implant ofclaim 1, wherein the nasal implant includes two or more differentmaterials.
 34. The implant of claim 1, wherein the implant is made of amaterial selected from the group consisting of: a poly(lactide); apoly(glycolide); a poly(lactide-co-glycolide); a poly(lactic acid); apoly(glycolic acid); a poly(lactic acid-co-glycolic acid);poly(lactide)/poly(ethylene glycol) copolymers; apoly(glycolide)/poly(ethylene glycol) copolymers; apoly(lactide-co-glycolide)/poly(ethylene glycol) copolymers; apoly(lactic acid)/poly(ethylene glycol) copolymers; a poly(glycolicacid)/poly(ethylene glycol) copolymers; a poly(lactic acid-co-glycolicacid)/poly(ethylene glycol) copolymers; a poly(caprolactone);poly(caprolactone)/poly(ethylene glycol) copolymers a poly(orthoester);a poly(phosphazene); a poly(hydroxybutyrate) or a copolymer including apoly(hydroxybutyrate); a poly(lactide-co-caprolactone); a polycarbonate;a polyesteramide; a polyanhidride; a poly(dioxanone); a poly(alkylenealkylate); a copolymer of polyethylene glycol and a polyorthoester; abiodegradable polyurethane; a poly(amino acid); a polyetherester; apolyacetal; a polycyanoacrylate; a poly(oxyethylene)/poly(oxypropylene)copolymer, poly-L-lactic acid (PLLA), poly-D-lactic acid (PDLA),poly-D,L-lactic acid (PLDLLA), or a blend or copolymer thereof.
 35. Theimplant of claim 1, wherein the proximal end includes an atraumaticrounded tip.
 36. The implant of claim 1, wherein an outer surface of thenasal implant includes a plasma treated portion.
 37. The implant ofclaim 36, wherein the plasma treated portion has an increasedhydrophilicity.
 38. The implant of claim 36, wherein the plasma treatedportion has an increased hydrophobicity.
 39. A nasal implant comprising:a central body having a proximal end and a distal end; a first armdisposed at the distal end, the first arm having a proximal end fixed tothe distal end of the central body and a distal end not fixed to thebody, the distal end of the first arm being adapted to move away from acentral longitudinal axis of the central body from a deliveryconfiguration toward a deployed configuration; and a second arm having aproximal end fixed to the distal end of the central body and a distalend not fixed to the body, the distal end of the second arm beingadapted to move away from a central longitudinal axis of the centralbody from a delivery configuration toward a deployed configuration;wherein the implant has a first stiffness along a first plane of thecentral body and a second stiffness along a second plane of the centralbody.
 40. The nasal implant of claim 39, wherein the first plane isformed by the first arm and the second arm in the deployedconfiguration.
 41. The implant of claim 40, wherein the second stiffnessis less than the first stiffness.
 42. The implant of claim 39, whereinthe first stiffness or the second stiffness is about 70 N*mm² to about150 N*mm².
 43. The implant of claim 39, wherein the first stiffness orthe second stiffness is about 90 N*mm² to about 105 N*mm².
 44. The nasalimplant of claim 39, wherein the second plane is orthogonal to the firstplane.
 45. The implant of claim 39, further comprising: a stiffnessmodification adapted to provide the first stiffness and the secondstiffness.
 46. The implant of claim 45, wherein the stiffnessmodification includes one or more notches or grooves along at least aportion of a longitudinal length of the central body.
 47. The implant ofclaim 45, wherein the stiffness modification includes flattened surfaceson opposing sides of the central body.
 48. The implant of claim 47,wherein the stiffness modification includes a stress distributing ribalong the length of the flattened surfaces.
 49. The implant of claim 45,wherein the stiffness modification includes one or more openings alongthe central body.
 50. The implant of claim 45, wherein the stiffnessmodification includes a hollow core along the central body.
 51. Theimplant of claim 45, wherein the stiffness modification includes atapered cross-section along an axis of the central body with a largercross-section adjacent the distal end and a smaller size towards theproximal end.
 52. The implant of claim 45, wherein the stiffnessmodification includes the central body having a plurality of differentcross-section sizes including a first cross-section adjacent the distalend of the central body, a second-cross section adjacent thefirst-cross-section, and a third cross-section adjacent to thesecond-cross-section and the proximal end of the central body, whereinthe first cross-section is larger than the second-cross section and thesecond cross-section is larger than the third cross-section.
 53. Theimplant of claim 45, wherein the stiffness modification includes ascalloped pattern on an outer surface of the central body.
 54. Theimplant of claim 45, wherein the stiffness modification includes a stiffinner material and a more flexible outer material.
 55. The implant ofclaim 45, wherein the stiffness modification includes the central bodyhaving a patterned outer surface with undulations having a varyingfrequency.
 56. The implant of claim 45, wherein the stiffnessmodification includes a plurality of directional fibers within theimplant.
 57. The implant of claim 45, wherein the stiffness modificationincludes a patterned second material on an outer surface of the centralbody.
 58. The implant of claim 45, wherein the stiffness modificationincludes a repeating pattern on an outer surface of the central bodywith a first larger cross-section and a second smaller cross-section.59. The implant of claim 45, wherein the stiffness modification includesa plurality of articulating sections that provide flexibility along aplane orthogonal to the plane defined by the first arm and the secondarm in the deployed configuration.
 60. The implant of claim 39, whereinthe central body has a tapering outside diameter that decreases from thedistal end towards the proximal end.
 61. The implant of claim 39,wherein the central body includes a plurality of undulations therein.62. The implant of claim 61, wherein a diameters of the undulationsincrease from the distal end to the proximal end.
 63. The implant ofclaim 62, wherein the central body includes a tapered core therein suchthat the diameter of the inner core decreases from the distal end to theproximal end.
 64. The implant of claim 61, wherein there are between 6and 24 undulations along an entire length of the central body.
 65. Theimplant of claim 39, further comprising a plurality of openings in thecentral body portion adapted to allow tissue ingrowth.
 66. The implantof claim 39, further comprising a plurality of openings in the first andsecond arms adapted to allow tissue ingrowth.
 67. The implant of claim39, wherein the central body includes a hollow or open structure along acentral longitudinal axis of the implant.
 68. The implant of claim 39,wherein the central body includes a solid structure along a centrallongitudinal axis of the implant.
 69. The implant of claim 39, whereinthe central body comprises a closed pitch spiral configuration.
 70. Theimplant of claim 39, wherein the central body comprises auni-directional helix spiral configuration.
 71. The implant of claim 39,wherein the central body comprises a bi-directional helix spiralconfiguration.
 72. The implant of any of claim 39, wherein the centralbody comprises an open coil configuration.
 73. The implant of claim 39,wherein the central body comprises a solid shaft with a spiral cut outersurface.
 74. The implant of claim 39, wherein the central body comprisesa solid shaft with a dual, bi-directional spiral cut outer surface. 75.The implant of claim 39, further comprising a first faceted tip on thedistal end of the first arm and a second faceted tip on the distal endof the second arm.
 76. The implant of claim 39, further comprising afirst sharpened tip on the distal end of the first arm and a secondsharpened tip on the distal end of the second arm.
 77. The implant ofclaim 76, wherein the faceted tip or sharpened tip includes a surfaceformed from a planar cut at an angle of 45 degrees or less.
 78. Theimplant of any of claim 76, wherein the faceted tip or sharpened tipincludes a surface formed from a planar cut at an angle of 35 degrees orless.
 79. The implant of any of claim 76, wherein the faceted tip orsharpened tip includes two or more surfaces formed from planar cuts. 80.The implant of any of claim 39, wherein the first arm and the second armhave an offset configuration such that, in the delivery configuration,the first arm and second arm overlie each other along or adjacent to thecentral longitudinal axis of the body.
 81. The implant of claim 39,wherein the body consists essentially of a bioabsorbable material. 82.The implant of claim 39, wherein at least one portion of the implant iscomposed of a bioabsorbable material.
 83. The implant of claim 39,wherein the nasal implant includes two or more different materials. 84.The implant of claim 39, wherein the implant is made of a materialselected from the group consisting of: a poly(lactide); apoly(glycolide); a poly(lactide-co-glycolide); a poly(lactic acid); apoly(glycolic acid); a poly(lactic acid-co-glycolic acid);poly(lactide)/poly(ethylene glycol) copolymers; apoly(glycolide)/poly(ethylene glycol) copolymers; apoly(lactide-co-glycolide)/poly(ethylene glycol) copolymers; apoly(lactic acid)/poly(ethylene glycol) copolymers; a poly(glycolicacid)/poly(ethylene glycol) copolymers; a poly(lactic acid-co-glycolicacid)/poly(ethylene glycol) copolymers; a poly(caprolactone);poly(caprolactone)/poly(ethylene glycol) copolymers a poly(orthoester);a poly(phosphazene); a poly(hydroxybutyrate) or a copolymer including apoly(hydroxybutyrate); a poly(lactide-co-caprolactone); a polycarbonate;a polyesteramide; a polyanhidride; a poly(dioxanone); a poly(alkylenealkylate); a copolymer of polyethylene glycol and a polyorthoester; abiodegradable polyurethane; a poly(amino acid); a polyetherester; apolyacetal; a polycyanoacrylate; a poly(oxyethylene)/poly(oxypropylene)copolymer, poly-L-lactic acid (PLLA), poly-D-lactic acid (PDLA),poly-D,L-lactic acid (PLDLLA), or a blend or copolymer thereof.
 85. Theimplant of claim 39, wherein the proximal end includes an atraumaticrounded tip.
 86. The implant of claim 39, wherein an outer surface ofthe nasal implant includes a plasma treated portion.
 87. The implant ofclaim 86, wherein the plasma treated portion has an increasedhydrophilicity.
 88. The implant of claim 86, wherein the plasma treatedportion has an increased hydrophobicity.